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Lymecycline 408 Mg Capsules Hard

Document: leaflet MAH GENERIC_PL 20117-0096 change

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT



Lymecycline

408 mg Capsules, hard

Lymecycline


M9RNINGSIDE

HEALTHCARE


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 you have any further 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 yours.

-    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

-    The full name of this medicine is Lymecycline 408 mg Capsules, hard, but in this leaflet it will be referred to as Lymecycline capsules, or lymecycline.

What is in this leaflet

1.    What Lymecycline capsules are and what they are used for

2.    What you need to know before you take Lymecycline capsules

3.    How to take Lymecycline capsules

4.    Possible side effects

5.    How to store Lymecycline capsules

6.    Contents of the pack and other information


1. Wha Lymecycline capsules are and what they are used for


Lymecycline capsules belong to a group of medicines called tetracycline antibiotics. It is used to treat acne; which appears as blackheads or whiteheads, which people often refer to as pimples or spots.

This medicine can also be used to treat other infections, such as:

•    Acute sinusitis,

•    Bronchitis,

•    Infections in the abdomen,

•    Some types of eye infections called trachoma,

•    Soft skin infections.

Your doctor will tell you what you are being treated for.


•    Diuretics, used to treat kidney disease, heart

disease, or high blood pressure.    ^

•    Medicines for epilepsy, such as phenobarbitone, phenytoin, and carbamazepine.

•    An anesthetic called methoxyflurane.

Lymecycline capsules with food, drink and alcohol

Absorption of Lymecycline capsules is not affected by moderate amounts of milk, such as a glass. Lymecycline capsules should always be taken with a glass of water.

It is better not to drink alcohol while taking this medicine.

Pregnancy, breast-feeding and fertility

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.

Lymecycline capsules must not to be taken if you are pregnant or breast-feeding.

Use of medicines such as Lymecycline capsules may affect the proper growth of developing teeth or bones, and lead to permanent tooth discolouration.

Driving and using machines

No studies on the e ects on the ability to drive and use machines have been done. Since this medicine may cause dizziness or eyesight disturbances, you should make sure you are not a ected before driving or operating machinery.

Lymecycline capsules contain Tartrazine, E102: this may cause allergic reactions.


3. How to take Lymecycline capsules


2. What you need to know before you take Lymecycline capsules


Do not take Lymecycline capsules:

-    if you are allergic to Lymecycline, or to other teracyclines, or any of the other ingredients of this medicine (listed in section 6).

-    if you are pregnant or breast-feeding.

-    if you have ever had kidney disease.

-    if you are a child under the 12 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before taking Lymecycline capsules:

-    if you have had liver problems.

-    if you have had kidney problems.

-    if you suffer from an allergic condition that causes joint pain, skin rashes, or fever (called systemic lupus erythematosus).

-    if you suffer from a disease that weakens the muscles, called myasthenia gravis.

You should avoid direct exposure to sunlight, or artificial sunlight from sunbeds. If you experience skin discomfort, then stop taking this medicine and seek advice from your doctor.

Children and adolescents

Lymecycline is not recommended for use in children aged under 12 years of age as it can cause permanent discolouration of tooth enamel, and affect development of the bones.

Other medicines and Lymecycline capsules

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines that you buy without prescription.

Do not take the following medicines at the same time as Lymecycline capsules, take them at least two hours before, or two hours after Lymecycline capsules:

•    Indigestion remedies.

•    Ulcer healing medicines.

•    Quinapril (for high blood pressure).

•    Supplements containing Calcium, Aluminium, Magnesium, Zinc, or Iron.

Tell your doctor if you are taking any of the following medicines:

•    Oral retinoids, used to treat acne.

•    Anticoagulants, used to stop blood clotting.


Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adults and children over 12 years:

Acne: the normal dose is one capsule once a day, preferably in the morning. Lymecycline capsules should always be taken with a glass of water.

How long you will have to take Lymecycline capsules for will depend on how quickly your condition improves. For acne this will normally be a minimum of eight weeks.

Infections: For other infections the usual dose is one Lymecycline capsule twice a day.

Your doctor may recommend a higher or lower dose; this depends upon the type and severity of the infection. Ask your doctor if you are unsure. Lymecycline capsules should always be taken with a glass of water.

Use in children and adolescents

Lymecycline capsules are not recommended for use in children under 12 years of age as they can cause permanent discolouration of tooth enamel and a ect bone development.

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If you take more Lymecycline capsules than you should

If you, or anybody else, takes too many capsules, or you think a child may have swallowed any, contact your nearest hospital casualty department, or tell your doctor, immediately.

If you forget to take Lymecycline capsules

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, take it as soon as you remember it, and then take the next dose at the right time.

If you stop taking Lymecycline capsules

Acne and other infections respond slowly to antibiotics. It is very important that you take all the Lymecycline capsules that your doctor has prescribed for you. If you stop taking Lymecycline capsules too soon, your acne or infection could get worse, or could come back.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.



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What Lymecycline capsules look like and contents of the pack

Like all medicines, this medicine can cause side    Lymecycline capsules are hard gelatin capsules,

effects, although not everybody gets them.    with a red caP, and a yellow body, and contain a

yellow coloured powder.

If you experience any of the following serious

side effects, stop taking the capsules and    Pack sizes: 7, 14, 28, 56, or 112 capsules in

immediately tell your doctor, or go to the nearest aluminium - aluminium blister strip. hospital accident and emergency department:    Not all packs may be be marketed.


4. Possible side effects


Unknown frequency of occurrence (cannot be estimated from available information):

•    Serious allergic reaction, causing swelling of the face, tongue, and throat that can cause great difficulty in breathing.

•    Severe peeling and swelling of the skin, blistering of the skin, mouth, eyes, sex organs, and fever. Skin rash with pink - red blotches, especially on palms of hands, or soles of feet, which may blister.

Lymecycline capsules may also cause the following side effects.

Common (occur in less than 1 in 10 patients):

•    Feeling sick (nausea).

•    Abdominal pain.

•    Diarrhoea.

•    Headache.


Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Morningside Healthcare Ltd 115, Narborough Road Leicester, LE3 0PA United Kingdom

Manufacturer:

Laboratorios Atral, S.A.

Rua da Estagao, 42

Vala do Carregado

2600-726 Castanheira do Ribatejo

Portugal

T his leaflet was last revised in April 2016


Unknown (frequency cannot be estimated from available information):

•    Eyesight disturbances.

•    Dizziness.

•    Being sick (vomiting).

•    Yellowing of eyes or skin (jaundice).

•    Increased sensitivity of the skin to sunlight (real or artificial).

•    Increased pressure in the brain.

•    Changes in type or number of certain blood cells.

•    Pain in the upper part of the abdomen.

•    Changes in some blood tests (liver function tests).

•    Fever.

•    Itchiness, skin rash, or hives.

•    Inflammation of the intestine.


The following side effects may occur during treatment with the class of medicines to which Lymecycline capsules belongs (the tetracyclines):

•    Inflammation or ulceration of the gullet, causing pain, or difficulty swallowing, or painful heartburn.

•    Difficulty in swallowing.

•    Liver damage.

•    Tee th discolouration.

•    Inflammation, or soreness, of the tongue, mouth, gums, lips, or cheeks.

•    Soreness or itching of the genital (crotch) area.

•    Yeast infection around the genital (crotch) or anus.

•    Infection of the colon (part of the lower intestine).

•    Permanent visual loss.


Reporting of side effects

If you get 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.


5. How to store Lymecycline capsules


Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.

Store below 25°C.

Store in the original package.

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 help protect the environment.


6. Contents of the pack and other information


What Lymecycline capsules contain

-    The active substance is lymecycline; each capsule contains 408 mg of lymecycline equivalent to 300 mg tetracycline base.

-    The other ingredients (excipients) are: colloidal anhydrous silica, and magnesium stearate.

-    The capsule body (yellow) contains: gelatin, tartrazine (E 102), and titanium dioxide (E 171).

-    The capsule cap (red) contains: gelatin, indigo carmine (E 132), erythrosine (E 127), and titanium dioxide (E 171).


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