Aizea 75 Microgram Film-Coated Tablets
K
CLIENTE:
CLIENT:
|
NClMERO de PLANO: PAfS/ES: GRAN BRETANA PLAN NUMBER: COUNTRY/IES: GREAT BRITAIN |
N°. PRUEBA: FECHA: no OfM K N°. PROOF: Ut> DATE: 11.U2.2Ul0 | ||||
|
Medidas prospecto plano/desplegado: ooq ESCALA: Anno/ Leaflet measures flat/unfolded: ZZOX l/Umm SCALE: 1UU/o |
Calidad y gramaje del papel: cn nr/m2 Quality and weight of the paper: OU gr/m . | ||||
|
Colores: NEGRO /BLACK Colors: 100% | |||||
|
1 Codigo de Barras yr Codigo Laetus I I Codigo Braille I I Reservas para fecha y caducldad I I Reservas para acabados (barnices,...) J Barcode Laetus code |_| Braille code |_| Reserves to date and expiration time |_| Reserves for finished (varnishes,...) | |||||
|
Otras especificaciones tecnicas: Another technical details: | |||||
|
Llneas de code, de plegado o referencias tecnicas. NO imprimibles Cutting or folding lines or technical references. NON-printable anverso / front | |||||
* El Cliente serd responsable de los contenidos aprobados en el diseno, texto y colores del prospecto, aluminio y estuche. Por tanto, el Cliente ser£ quien se harS cargo de cualquier reclamacibn, coste y/o gasto referente a la falta de exactitud y precisibn de dicha informacidn, y eximirS y mantendri indemne a CYNDEA PHARMA en relacibn a cualquier tipo de reclamaci6n, pago y/o gasto referente a la exactitud y precisi6n de dicha informacidn.
* Client shall be responsible for the contents of the artworks approved, text and colours of the lea ets aluminium foil, and cartons. Therefore, Client shall bear any and all cost and/or expense, and it shall keep CYNDEA PHARMA harmless from any claim, cost and/or expenses, relating to the curreciness and accuracy of such information.
|
8 |
8 |
|
^mrn^i |
| mm |
Contact your doctor as soon as possible if:
• you notice possible signs of a blood clot (e.g. severe pain or swelling in either of your legs); unexplained pains in the chest, breathlessness, an unusual cough, especially when you cough up blood);
• you have a sudden, severe stomach ache or jaundice (you may notice yellowing of the skin, the whites of the eyes, or dark urine, possibly a sign of liver problems);
• you feel a lump in your breast (possibly a sign of breast cancer);
• you have a sudden or severe pain in the lower abdomen or stomach area (possibly a sign of an ectopic pregnancy - a pregnancy outside the womb);
• you are to be immobilised or are to have surgery (consult your doctor at least four weeks in advance);
• you have unusual, heavy vaginal bleeding.
• you suspect that you are pregnant.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Aizea 75 microgram film-coated tablet Desogestrel
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Keep this leaflet.You may need to read it again.
If youhave anyfurther questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as Ifyouget any side effects, talk to your doctor or pharmacist.This includes any possible side effects notlisted inthis leaflet. See section 4.
What is in this leaflet
1. What Aizea is and what it is used for
2. What you needtoknow before you takeAizea
3. How totake Aizea
4. Possible side effects
5. How to store Aizea
6. Contents ofthe pack and other information
1. What Aizea is and what it is used for
• Aizea is usedtoprevent pregnancy.
• There are 2 main kinds ofhormone contraceptive.
The combined pill,"The Pill',which contains 2 types offemale sex hormone, an oestrogen anda progestogen The progestogen-onlypill, POP or mini-pill, which doesn'tcontain an oestrogen.
• Aizea is aprogestogen-only-pill (POP).
• Aizea contains asmallamount of one type offemale sex hormone,theprogestogen desogestrel.
• Most POPs work primarily by preventing the sperm cells from entering the womb but they do not always prevent the egg cell from ripening, which is the main way that combined pills work.
• Aizea is different from other most POPs in having a dose that in most cases prevents the egg cell from ripening. As a result, Aizea is a highly effectivecontraceptive.
• In contrastto thecombined pill, Aizea can be used by women who do not tolerateoestrogens and by women who arebreastfeeding
A disadvantageis that vaginal bleeding may occur atirregular intervals during the use ofAizea. On theotherhandyou may not have any bleeding at all.
2. What you need to know before you take Aizea
Aizea, likeotherhormonal contraceptives, does not protect against HIV infection (AIDS)orany other sexually transmitteddisease.
Do nottake Aizea:
• ifyou are allergic to desogestrelorany oftheingredients ofthis medicine (listed in section 6).
• ifyou are pregnantorthink you might bepregnant.
• if you have a thrombosis. Thrombosis is the formation of a blood clot in a blood vessel (e.g. of the legs (deep venous thrombosis) or the lungs (pulmonary embolism)).
• if you have or have had jaundice (yellowingof the skin) or severe liverdiseaseand your liver isstillnot working normally.
• if you have or ifyouare suspected of having a cancer that grows under the influence of sex-steroids, such ascertain types of breast cancer.
• if you have any unexplained vaginal bleeding.
If any ofthese conditions apply to you, tell your doctor beforeyou start to use Aizea.Your doctormay advise you tousea non-hormonal method of birth control. If any ofthese conditions appear forthe firsttime while using Aizea, consult yourdoctor immediately.
Warnings and precautions
Talktoyour doctororpharmacist before taking Aizea, if
• you haveeverhad breast cancer.
• you haveliver cancer, sincea possible effect of Aizea cannot be excluded.
• you have everhad a thrombosis.
• you have diabetes.
• you sufferfrom epilepsy (See section'Taking other medicines').
• you have tuberculosis (See section 'Taking othermedicines').
• you have high blood pressure.
• you have or have had chloasma (yellowish-brown pigmentation patches on the skin, particularly of the face); if so avoid too much exposuretothesun or ultraviolet radiation.
When Aizea is used in the presence of any of these conditions, you may need to be kept under close observation.Your doctor can explain what to do.
Breast cancer j
• Itis important to regularly check yourbreasts and you should contactyour doctoras soon as possible if youfeel anylumpin your breasts.
• Breast cancer has been found slightly more often in women who take the Pill than in women of the same age who do not take the Pill. If women stop taking the Pill, this reduces the risk, so thatlOyears after stoppingthe Pill, the riskis the same asfor womenwho have never taken the Pill.
lllllll
Breast cancer is rare under 40 years of age but the risk increases as the woman gets older. Therefore, the extra number of breast cancers diagnosed is higher if a woman continuesto take the Pill when she is older. How longshe takesthePillis less important.
• In every 10 000 women who take the Pill for up to 5 years but stop taking it by the age of 20, there would be less than 1 extra case of breast cancer found up to 10 years after stopping, in addition to the 4 cases normally diagnosed inthisage group.
• In 10 000 women who take the Pill for up to 5 years but stop taking it by the age of 30, there would be 5 extra cases in addition to the 44 casesnormally diagnosed.
• In 10 000 womenwho take the Pill forup to 5 years but stop taking it bytheage of 40,there would be 20 extra cases inaddition to the 160 casesnormally diagnosed.
Therisk ofbreast cancer in users of progestogen-only pillslike Aizea isbelievedtobe similartothat inwomen who use the Pill,but the evidenceis less conclusive.
Breast cancers foundin women who take the Pill,seem less likely to have spread thanbreastcancers found in women who do not takethe Pill.
Itis notcertain whetherthe Pill causes the increasedrisk of breast cancer.
Itmay be that the women were examinedmore often, so that the breastcancer is noticed earlier.
Thrombosis
See yourdoctor immediately if younotice possible signsof a thrombosis (seealso'Regular check-ups').
Thrombosis is the formation of a blood clot, which may block a blood vessel. A thrombosis sometimes occurs in the deep veins ofthe legs (deep venousthrombosis). Ifthis clotbreaks away fromthe veins where it is formed, it may reachand block thearteries ofthe lungs, causing aso- called "pulmonary embolism".A pulmonary embolism can cause chest pain, breathlessness, collapse or evendeath.
• Deep venous thrombosis is a rare occurrence. It can develop whether or not you are taking the Pill. It can also happen if you become pregnant.
The risk is higher in Pill-users than in non-users. The risk with progestogen-only pills like Aizea is believed to be lower than in users of Pills that also contain oestrogens (combined Pills).
Childrenandadolescents
No clinical dataon efficacy and safety are available inadolescentsbelow 18 years.
Other medicines and Aizea
Tellyour doctor, pharmacist, or Family Planning Nurse ifyou are taking, have recently taken or might take any othermedicines.
Some medicines may stopAizeafrom working properly.Theseinclude medicines used forthetreatment of
• epilepsy (e.g.primidone,phenytoin, carbamazepine,oxcarbazepine,felbamate and phenobarbital)
• tuberculosis (e.g. rifampicin)
• HIVinfections (e.g.ritonavir), or other infectious diseases(e.g. griseofulvin)
• stomach upset (medical charcoal)
• depressive moods(the herbal remedy St. John'sWort).
Your doctor cantellyou if youneed to take additional contraceptive precautions and if so, for how long.
Aizea may also interfere with how certain medicines work, causing either an increase in effect (e.g. medicines containing cyclosporine) or a decrease in effect.
Pregnancy, breast-feeding and fertility
Pregnancy - Do not use Aizea if you are pregnant, or thinkyou may be pregnant.
Breast-feeding - Aizea maybe usedwhile you are breast-feeding.
Desogestreldoesnot influence the production or thequality of breast milk.
However,a small amount oftheactive substance ofAizea passes over into the milk.
The health of children who were breast-fed for 7 months while their mothers were using desogestrel has been studied up until they were 2% years of age.No effects on theqrowth anddevelopmentof the childrenwere observed.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Aizea hasno known effect on theability to driveor use machines.
Aizea contains lactose (milksugar)
Ifyou havebeen told by your doctor that you havean intolerance to some sugars, contactyour doctorbeforetaking this medicinal product. Regular Check-ups
When you are using Aizea, your doctor will tell you to return for regular check-ups. In general, the frequency and nature of these check-ups will depend on your personal situation.
PLEASE TURN OVER
700087 / 352
170 mm
38,00 mm i 38,00 mm
aprox. / about I aprox. / about
228 mm
|
APROBAClON del CLIENTE: CLIENT APPROVAL: |
aprobaciOn de Cyndea J PHARMA |
APPROVAL: | |
|
Fecha: |
Firma: |
Fecha: |
Firma: |
|
Date: |
Signature: |
Date: |
Signature: |
K
CLIENTE:
CLIENT:
|
NClMERO de PLANO: PAfS/ES: GRAN BRETANA PLAN NUMBER: COUNTRY/IES: GREAT BRITAIN |
N°. PRUEBA: FECHA: .. nooniR N°. PROOF: UO DATE: 11.U2.2Ul0 | ||
|
Medidas prospecto plano/desplegado: ooq ESCALA: Anno/ Leaflet measures flat/unfolded: ZZOX l/Umm SCALE: 1UU/o |
Calidad y gramaje del papel: cn nr/m2 Quality and weight of the paper: OU gr/m . | ||
|
Colores: NEGRO /BLACK Colors: 100% | |||
|
"1 Codigo de Barras | | Codigo Laetus | | Codigo Braille | | Reservas para fecha y caducldad | | Reservas para acabados (barnices,...) |_| Barcode |_| Laetus code |_| Braille code |_| Reserves to date and expiration time |_| Reserves for finished (varnishes,...) | |||
|
Otras especificaciones tecnicas: Another technical details: |
Llneas de code, de plegado 0 referencias tecnicas. NO imprimibles Cutting or folding lines or technical references. NON-printable reverso / back | ||
* El Cliente serd responsable de los contenidos aprobados en el diseno, texto y colores del prospecto, aluminio y estuche. Por tanto, el Cliente ser£ quien se harS cargo de cualquier reclamacibn, coste y/o gasto referente a la falta de exactitud y precisibn de dicha informacidn, y eximirS y mantendri indemne a CYNDEA PHARMA en relacibn a cualquier tipo de reclamaci6n, pago y/o gasto referente a la exactitud y precisi6n de dicha informacidn.
* Client shall be responsible for the contents of the artworks approved, text and colours of the lea ets aluminium foil, and cartons. Therefore, Client shall bear any and all cost and/or expense, and it shall keep CYNDEA PHARMA harmless from any claim, cost and/or expenses, relating to the curreciness and accuracy of such information.
|
8 |
8 |
|
mm | |
| mm |
3. How to take Aizea
Alwaystake this medicineexactly as yourdoctor or pharmacist has told you. Checkwith yourdoctor or pharmacistif you are not sure.
When and how to take the tablets?
Each strip of Aizea contains28 tablets- 4 weeks supply.
• Take yourtablet each dayat about the same time. Swallow the tablet whole, with water.
• Arrows are printed on the front of the strip, between the tablets. The days of the week are printed on the back of the strip. Each day corresponds withone tablet.
• Every time you start a new strip of Aizea, take a tablet from the top row. Don't start with just any tablet. For example if you start on a Wednesday, you must take thetablet from the toprow marked (on the back) withWED.
• Continue to take one tablet at every day until the pack is empty, always following the direction indicated by the arrows. By looking at the backof your pack you caneasily check ifyou have already taken your tablet on a particular day.
• You may have somebleedingduringtheuseof Aizea, (SeeSection 4 - Side Effects) but youmust continueto take your tablets asnormal.
• When astripis empty, you must start with anew stripof Aizea on thenext day - withoutinterruption and without waiting for ableed. Starting your firstpack ofAizea
If you are not using hormonal contraception at present (or in the past month) wait for your period to begin. On the first day of your period take the first Aizea tablet. Additionalcontraceptive precautions are not necessary.
If you take your first tablet ondays 2 to 5 of yourperiod use an additional barrier methodof contraception forthefirst7 days of tablet-taking. When you change from a combined pill (COC), vaginal ring,or transdermal patch.
If you have a tablet-, ring- or patch-freebreak
• You can also start at the latest the day following the tablet-, ring-, patch-free break, or when you have taken all the inactive (placebo) tablets, ofyour presentcontraceptive.
• If you follow these instructions, make sure you use an additional barrier method of contraception for the first 7 days of tablet-taking.
If you don't have a tablet-, ring- or patch-free brea k
• Start taking Aizea onthe day afteryou take the last tablet from the present Pill pack, or on the day of removal ofyour vaginal ring or patch (this means notablet-, ring- or patch-free break).
• If your present Pill pack also contains inactive (placebo) tablets you can start Aizea on the day after taking the last active tablet (if you are not surewhich this is, ask your doctor or pharmacist).
• Ifyoufollow theseinstructions, additional contraceptive precautions arenot necessary.
When changing from another progestogen-only pill
Switch onany day from another mini pill. Additional contraceptive precautions arenot necessary.
When changing from an injection, implant ora hormonal IUS
Start using Aizea when your next injection is due or on the day that your implant or your IUS is removed. Additiona l contraceptive precautions are not necessary.
Afteryou have ababy
You can start Aizea between 21 to 28 days after thebirth of yourbaby.
If you start later, make sure that during the first cycle you use an additional barrier method of contraception until you have completed the first 7 days of tablet-taking.
However, if you have already had sex, check that you are not pregnant before starting Aizea. Information for breast-feeding women can be found in section 2"Before you take Aizea" in the paragraph"Pregnancy and breast-feeding".Your doctor can also advise you.
After amiscarriage or an abortion
Your doctor will adviseyou.
If you take more Aizea than you should
There have been no reports of serious harmful effects from taking too many Aizea tablets at one time. Symptoms that may occur are nausea, vomiting and in younggirls, slight vaginal bleeding.
For more information askyour doctorfor advice.
If you forget to takeAizea If you are less than 12 hours late:
• Take the missed tablet as soon asyou remember andtake the next one at theusual time. Aizea will still protect you from pregnancy.
If you are more than 12 hours late:
• If you are more than 12 hours late in taking any tablet, you may not be completely protected against pregnancy. The more consecutive tablets you h ave mi ssed, the higher the risk that youmightfall pregnant.
• Take a tablet as soon as you remember and take the next one at the usual time.This may mean taking two in one day.This is not harmful. (If you have forgotten more than one tablet you don't need to take the earlier missed ones). Continue to take your tablets as usual for the next7 days butyou must also use an extra method, such as a condom, for the next7 days.
• If you are more than 12 hours late taking your tablet and have sex, it is safe to use emergency contraception; please consult your pharmacist or doctor.
• Ifyou missed one or more tablets in the very first weekof tablet-intake and had intercourse in the week before missing the tablets, you may fallpregnant. Ask yourdoctor for advice.
Ifyouvomitor use medical charcoal
Ifyou vomit, or use medical charcoalwithin 3 - 4 hours after taking your Aizea tablet or have severe diarrhoea, the active ingredient may not have been completely absorbed. Follow the advicefor forgotten tablets in the sectionabove.
If youstoptaking Aizea
You canstop taking Aizea whenever youwant. From theday youstop you are no longer protected againstpregnancy.
Ifyou haveany further questions onthe useof this medicine,ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, althoughnot everybody gets them.
Tellyour doctorif you noticeany unwanted effect, especially ifsevere or persistent.
Serious side effects associated with the use of Aizea are described in section 2"Before you take Aizea". Please read this section for additional information on'Breast cancer' and'Thrombosis, andconsult yourdoctor at once whereappropriate.
Vaginal bleeding may occur at irregular intervals while using Aizea.
This may be just slight staining which may not even require a pad, or heavier bleeding, which looks rather like a scanty period. You may need to use tamponsorsanitary towels.You may also nothave any bleeding at all.
Irregular bleeding is not a sign that Aizea is not working. In general, you need not take any action; just continue to take Aizea. If bleeding is heavy or prolonged youshouldconsultyour doctor.
How often are other possible side effects seen?
Common (affecting less than 1 in 10 women): mood changes, decreased sexual drive (libido), headache, nausea, acne, breast pain, irregular or no periods, weight increase.
Uncommon (affecting less than 1 in 100 women) infection of the vagina, difficulties in wearing contact lenses, vomiting, hair loss, painful periods, ovarian cysts, tiredness.
Rare (affecting lessthan 1 in 1000 women) skin conditions such as: rash, hives, painful blue-red skin lumps (erythema nodosum)
Apart fromthese side effects, breast secretion or leakage mayoccur.
You should see your doctor immediately if you experience symptoms of angioedema such as (i) swollen face, tongue or pharynx; (ii) difficulty to swallow; or (ii)hives and difficultiesto breathe.
Reporting ofside effects
Ifyouget any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.You can also report side effects directly via the national reportingsystemYellow Card Scheme Website: www.mhra.uk/yellowcard
By reporting sideeffects you can help provide moreinformationon the safety ofthis medicine.
5. How to store Aizea
Keep this medicine out of the sightand reach of children.
Do not use this medicine afterthe expiry datewhich is stated on the carton after EXP.The expiry daterefersto thelastday ofthat month.
This medicinalproductdoesnot require anyspecial storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will helpprotect the environment.
6. Contents of the pack and other information WhatAizea contains
- The activesubstance is desogestrel. Each tablet contains 75 microgramof desogestrel.
- The other ingredients are: colloidal anhydrous silica; Alpha -tocoph ero l; maize starch; povidone; stearic acid; hypromellose; macrogol 6000; propylene glycol, talc; titaniumdioxide (E171); lactose monohydrate (see also "Aizeacontainslactose"\n section 2).
What Aizealookslike and contents of the pack
White, cylindrical, biconvex film-coatedtabletwith a diameterof 6.00 mm approximately.
Aizea is packed in PVC / Aluminium blisters. Each individual blisteris placed inside a foil sachet,which is thenpacked into a cardboard box.
Packs with
28 filmcoated tablets 56 filmcoated tablets 84 filmcoated tablets 168 filmcoated tablets Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder
Besins Healthcare
Aven ue Louise 287, 1050 Brussels, B ELGIUM Manufacturer
Cyndea Pharma, S.L.
Pol. Ind. Emijiano Revilla Sanz Avenida deAgreda, 31 42110tilvega (Soria) SPAIN UK Distributor Besins Healthcare (UK) Ltd.
35A Hig h Street, Marlboroug h, UK, SN8 1LW
This medicinal product is authorised in the Member States of the EEA under the following names:
Belgium: Desogestrel Besins 75 microgrammes comprime pellicule
Czech Republic: Desogestrel Besins 75 mikrogramu Potahovane tablety
France: Antigone 75 microgrammes, comprime pellicule
Germany: onefra sanol 75 Mikrogramm Filmtabletten
Luxemburg: Desogestrel Besins 75 microgrammes comprime pellicule
Poland: Dezogestrel Besins 75 mikrogramow,tabletki powlekane
Slovak Republic: Dezogestrel Besins 75 mikrogramov filmom obalene tablety
United Kingdom: AIZEA 75 microgram film-coated tablets microgram film-coated tablets
This leaflet was last revised31 October 2014.
700087 / 352
|
APROBAClON del CLIENTE: CLIENT APPROVAL: |
aprobaciOn de Cyndea •* PHARMA |
APPROVAL: | |
|
Fecha: |
Firma: |
Fecha: |
Firma: |
|
Date: |
Signature: |
Date: |
Signature: |
Cyndea
PHARMA
|
Codigo |
Laetus |
version |
fecha |
descripcion de cambios / modificaciones |
orden |
|
700087 |
352 |
01 |
25.03.2014 |
1. Diseno inicial (150x315mm) |
BESINS |
|
02 |
27.03.2014 |
1. Modificacion medidas y gramaje. De 150x315mm y 80 gr/m2. a 170x297mm y 60 gr/m2. |
CYNDEA | ||
|
03 |
30.01.2015 |
1. Modificaci6n composici6n. De formato vertical 170x297mm a horizontal 228x170mm. |
CYNDEA | ||
|
04 |
03.02.2015 |
1. Modificaci6n textos segun instmcciones de archivo dfa 03/02/2015: “PILaizea-tc-20150203.pdf” |
BESINS | ||
|
05 |
11.02.2015 |
1. Nueva composicidn (dos columnas en vez de tres). |
BESINS |