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2. Priadel 400mg Prolonged Release Tablets

Document: leaflet MAH BRAND_PL 04425-0325 change

• leaflet MAH BRAND_PL 04425-0325
• leaflet MAH BRAND_PLPI 15814-1161
• leaflet MAH BRAND_PLPI 16369-1700
• leaflet MAH BRAND_PLPI 21828-0036

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Polices / Fonts : Ocean Sans/ZapfDin.

Texte corps mini / Text size mini : 8 pt Code actuel / Current code : 700142 Couleur (s) / Color(s) : 1 Bleu PMS Reflex Blue U Plan N° : N 84

Modification(s) apportee(s) a cette version / Modification(s) brought to this version :

•    Theophylline - used for wheezing or difficulty in breathing

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•    Medicines used to control your heart beat -such as quinidine, disopyramide, procainamide, amiodarone and sotalol.

•    Losartan, candesartan, irbesartan (called ‘angiotensin II receptor antagonists’)

•    Some medicines for indigestion and heartburn (antacids) - such as sodium bicarbonate and cisapride

•    Calcitonin - used for hypercalcaemia and Paget’s disease/acute bone loss

The following medicines can increase the chance

of side effects when taken with Priadel Tablets.

Tell your doctor if you are taking any of the

following before taking Priadel Tablets:

•    Some medicines used for depression (SSRIs), tricyclics and triptans derivatives - such as fluvoxamine, paroxetine or fluoxetine

•    Medicines used to calm emotional and mental illnesses - such as haloperidol, flupentixol, diazepam, thioridazine, amisulpride fluphenazine, chlorpromazine or clozapine. Coadministration with Priadel may increase the risk of a serious but rare side effect called 'neuroleptic malignant syndrome', which may be fatal

•    Methyldopa used for high blood pressure

•    Some medicines used for fits (epilepsy) - such as carbamazepine or phenytoin

•    Medicines used for chest pain (angina) or high blood pressure - such as diltiazem or verapamil

Priadel with food and drink

Your diet and the amount of fluid you drink while taking Priadel Tablets is very important (see section 3 below ‘Diet, food and drink while taking Priadel Tablets').

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breastfeeding.

Information for women who could become

pregnant

•    Talk to your doctor before taking this medicine if you plan to get pregnant, or think you may be pregnant. It is very important that you talk to your doctor about your treatment well before you become pregnant

•    You should use an effective method of contraception while taking Priadel Tablets

Information for women who are pregnant

•    If you find out you are pregnant while taking Priadel Tablets, tell your doctor straight away

•    Do not take Priadel Tablets if you are pregnant, especially in the first 3 months of your pregnancy

If your doctor decides that you should have Priadel Tablets while you are pregnant, he or she will:

•    Keep a close eye on the level of lithium in your blood. This is because your kidneys work differently while you are pregnant

•    Arrange for appropriate tests before your baby is born

If it is decided you should have Priadel Tablets during late pregnancy or during labour, your baby may appear ‘floppy’. This returns to normal without any treatment.

Breast-feeding

•    Do not breast-feed if you are taking Priadel Tablets. This is because small amounts may pass into the mother’s milk

Driving and using machines

Do not drive or use any tools or machines if you feel sleepy, tired or dizzy. Priadel Tablets may also cause other effects that can make it dangerous to drive or use tools and machines such as numbness, paralysis, weakness or fits (seizures).

Important information about some of the ingredients of Priadel Tablets

Your medicine contains mannitol (E421). This may cause mild diarrhoea.

3. How to take Priadel Tablets

Always take Priadel Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Diet, food and drink while taking Priadel Tablets

The amount you eat and drink is very important as it can affect the levels of Priadel Tablets in your blood.

•    Drink the same amount of fluids every day while taking Priadel Tablets. In hot environments or if you are dehydrated, you may need to drink extra fluids

•    Have a normal balanced diet while taking Priadel Tablets. Do not change your diet without talking to your doctor first

How to take your medicine

•    Take this medicine by mouth

•    Swallow the tablets whole. Do not crush or chew them

•    The tablets can be broken in half

•    Take your medicine at the same times every day

•    If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor

Adults weighing about 70kg

• The usual starting dose is between 400mg to 1,200mg each day

Elderly and adults weighing under 50kg

•    The usual starting dose is between 200mg to 400mg each day

•    Your doctor may decide to increase this dose by 200mg to 400mg every 3 to 5 days. Increasing the dose is usual, but do not do this unless your doctor tells you to

Polices / Fonts : Ocean Sans/ZapfDin.

Texte corps mini / Text size mini : 8 pt Code actuel / Current code : 700142 Couleur (s) / Color(s) : 1 Bleu PMS Reflex Blue U Plan N° : N 84

Modification(s) apportee(s) a cette version / Modification(s) brought to this version :

• The maximum dose will depend on your blood levels and illness

Use in children

Priadel Tablets are not recommended for children and adolescents.

Patients with kidney problems

Your doctor will monitor the level of lithium in your blood and adjust your dose accordingly. You should not take Priadel if you have severe kidney problems (see section 2).

Blood Tests

•    Within the first week of treatment your doctor will give you a blood test. This is to check the level of lithium in your blood

•    Your daily dose will be changed depending on the results of your blood test

•    Your doctor will carry out a blood test every week until the level of lithium in your blood is steady

•    You will then have your blood tested every 3 months to check the level remains steady

If you are going to have other types of blood test, tell the doctor or nurse that you are taking lithium.

If you take more Priadel Tablets than you should

If you or someone else has taken more Priadel Tablets than you should, talk to a doctor or go to your nearest hospital casualty department straight away. Remember to take the medicine pack with you. This is so the doctor knows what you have taken. The following effects may happen: feeling sick or being sick, blurred vision, increased need to pass water, lack of control over passing water or stools, feeling lightheaded or drowsy, confusion and blackouts. You may also experience shaking or muscle weakness, muscle twitches and jerks or spasms causing unusual movements of the face, tongue, eyes or neck. In severe cases you may lose consciousness, have fits, shortness of breath or chest pain.

If you forget to take Priadel Tablets

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

If you stop taking Priadel Tablets

Keep taking your medicine until your doctor tells you to stop. Do not stop taking Priadel Tablets just because you feel better. If you stop, your illness may return. When your doctor says that you can stop taking Priadel Tablets, your dose will be lowered gradually. Your doctor will help you to do this.

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

4. Possible side effects

Like all medicines, Priadel Tablets can cause side effects, although not everybody gets them. Side-effects are more likely to happen at the start of treatment.

Allergic reactions

If you have an allergic reaction, stop taking Priadel and see a doctor or go to a hospital straight away. The signs may include: rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.

Stop taking Priadel and see your doctor or go to a hospital straight away if you notice a combination of any of the following serious side effects:

The following side effects may be signs of

lithium toxicity (too much lithium in your blood):

•    Loss of appetite, diarrhoea and vomiting (being sick)

•    Muscle weakness, lack of co-ordination, muscle twitching or sudden jerks and shaking

•    Feeling drowsy or very tired, balance problems and feeling dizzy with a spinning sensation (vertigo)

•    Difficulty in walking or unusual involuntary movements, such as unusual eye movements

•    Ringing in the ears (tinnitus) or blurred vision

•    Difficulty in speaking or slurred speech

•    Altered mental state due to brain disease, damage or malfunction (encephalopathy)

Other serious side effects which need urgent

medical attention:

•    Swelling around the feet and ankles, face and stomach and weight gain due to water retention

•    Cloudy or foamy urine (water)

•    Feeling confused, dazed, delirious or loss of consciousness

•    Memory problems

•    Fits (seizures)

•    Irregular or slow heart beats, shortness of breath, chest pain and fainting

•    Involuntary eye movements

•    Abnormal muscle breakdown (rhabdomyolysis) which can lead to kidney problems

Frequency unknown:

• Benign/malignant kidney tumours

(microcysts, oncocytoma, or collecting duct renal carcinoma) (in long-term therapy)

Tell a doctor or pharmacist straight away if you

notice any of the following serious side effects:

•    Increased thirst and passing water (urine) more often than normal. You may also feel tired and hungry. This could be due to high blood sugar levels or a condition called ‘diabetes insipidus’

It is important to tell your doctor if you are passing more water than usual as the amount of Priadel you are taking may need to be changed

•    You have a swelling or a lump on your neck (which may be caused by an enlarged thyroid gland)

•    You have a fast heartbeat, sweating, stress (anxiety), increased appetite, loss of weight, weakness and are unable to tolerate heat. This could be due to higher levels of thyroid hormone in the blood (hyperthyroidism)

•    You feel tired, have cold skin and hair becomes dry, thinning of hair or fingernails, hoarse voice, joint or muscle pain and gain weight. This could be due to lower levels of thyroid hormone in the blood (hypothyroidism)

•    You have increased thirst, pass more water than usual, feel tired or depressed, muscle aches or pains, bone or joint pain and stomach upsets. This could be due to a hormone problem called ‘hyperparathyroidism’

•    You have indigestion or heartburn and are feeling sick, being sick or have abdominal pain. You may also have black tarry stools (faeces) or blood in your stools or you may notice blood or dark bits (like coffee grounds) when you are being sick. This could be due to a stomach problem called ‘gastritis’

Polices / Fonts : Ocean Sans/ZapfDin.

Texte corps mini / Text size mini : 8 pt Code actuel / Current code : 700142 Couleur (s) / Color(s) : 1 Bleu PMS Reflex Blue U Plan N° : N 84

Modification(s) apportee(s) a cette version / Modification(s) brought to this version :

•    Headaches, a ‘rushing’ sound in your ears and feeling or being sick. This could be because of increased pressure in the brain

•    Numbness, weakness and pain in the arms and legs (peripheral neuropathy)

Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days:

•    Hair loss or inflamed hair follicles

•    Acne, skin spots or rashes, skin ulcers and/or itching

•    Slight shaking of the hands

•    You have skin irritation and swelling. Skin may appear red, itchy with silvery scales (psoriasis). If you already have this condition, you could notice that it is getting worse

•    Feeling sick, a watery or dry mouth and/or changes in the way things taste

•    Stomach pain

•    Sexual problems including being unable to get an erection, having delayed ejaculation or being unable to have an orgasm

•    Blurred vision or blind spots in your eyesight

•    Uncontrolled movements of the eye

•    Weight gain

Tests

Blood tests may show an increase in white blood cells (leucocytosis) or changes in the way the kidney is working. They may also show changes in the levels of calcium or magnesium in your blood.

A test on your heart may show changes in the way your heart is working.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Priadel Tablets

•    Keep out of the reach and sight of children

•    Do not use Priadel Tablets after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month

•    Store below 25°C. Store in the original package to protect from moisture.

•    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment

What Priadel 400mg prolonged release tablets contain

•    Each tablet contains 400mg of the the active substance, lithium carbonate

•    The other ingredients are: Glycerol distearate, mannitol (E421), acacia spray dried, sodium laurilsulfate, magnesium stearate, maize starch and sodium starch glycolate (Type A).

What Priadel Tablets look like and contents of the pack

Priadel 200mg prolonged release tablets are white, scored, capsule-shaped tablets engraved with P200 on one side. They are supplied in blister packs of 100 tablets or securitainers of 100 or 500 tablets. Not all pack sizes may be marketed.

Priadel 400mg prolonged release tablets are white, circular, bi-convex tablets engraved PRIADEL on one side, scored on the other side. They are supplied in blister packs of 100 tablets or securitainers of 50, 100 or 1000 tablets or hospital packs of 100 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Tel: 0845 372 7101

email: uk-medicalinformation@sanofi.com Manufacturer

Delpharm Dijon, 6 Boulevard de l’Europe, 21800 Quetigny, France

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

This leaflet was last revised in December 2015

© Sanofi, 1985 - 2015

The MDF The Bipolar Organisation is a charity which can provide more information about Manic Depression/Bipolar Disorder. They can be contacted at:

MDF The Bipolar Organisation, Castle Works, 21 St. Georges Road, London SE1 6ES.

Telephone: 0207 793 2600 Fax: 0207 7932639 E-mail: mdf@mdf.org.uk

6. Contents of the pack and other information

What Priadel 200mg prolonged release tablets contain

•    Each tablet contains 200mg of the the active substance, lithium carbonate

•    The other ingredients are: Glycerol monostearate, glycerol distearate, mannitol (E421), acacia spray dried, sodium laurilsulfate, magnesium stearate, maize starch and sodium starch glycolate (Type A).

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