REMINYL (galantamine)

Reminyl 4 mg, 8mg and 12 mg Tablets (galantamine hydrobromide).

This leaflet contains important information.  Please read it carefully before taking your medicine. If you are a carer and will be giving Reminyl to the person you look after, it is also important that you read this leaflet on their behalf. If you have any questions or concerns after reading the leaflet, speak to your doctor or pharmacist.

WHAT IS REMINYL?

The name of this medicine is Reminyl, it contains the active ingredient galantamine hydrobromide. Reminyl comes in 3 different strengths of tablets, as indicated below:

• the off-white tablets contain 4 mg galantamine and are marked G4;
• the pink tablets contain 8 mg galantamine and are marked G8;
• the orange-brown tablets contain 12 mg galantamine and are marked G12;

The tablets also contain the inactive ingredients colloidal anhydrous silica, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propylene glycol, talc and titanium dioxide (E111).
The tablets contain the following coloring agents: 4mg tablets: yellow ferric oxide (E172); 8 mg tablets: red ferric oxide (E172); 12 mg tablets: red ferric oxide (E172) and orange yellow S aluminium lake (E110).
Warning: The coloring E110 in the 12mg tablets can cause an allergic reaction, like asthma, in some people. An allergic reaction to E110 is more likely in people who are allergic to aspirin (acetylsalicylic acid). Speak to your doctor for advice before taking any tablets. The 4 mg tablets come in packs of 14 tablets, the 8 mg tablets in packs of 14 or 56 and the 12 mg tablets in packs of 56 or 168. The marketing authorization for Reminyl is held by Shire Pharmaceuticals Limited, East Anton, Andover, Hampshire SP10 5RG, UK. The tablets are manufactured by Janssen-Cilag SpA, Via C Janssen, Borgo San Michelle, 04010 Latina, Italy.

WHAT IS REMINYL FOR?

Reminyl is used to treat the symptoms of mild to moderately severe dementia of the ~ Alzheimer type, a disease that alters brain function. The symptoms include progressive memory loss, increasing confusion and behavioral changes. As a result, sufferers find it becomes more and more difficult to carry out their normal daily activities. Symptoms of dementia of the A1zheimer type are believed to be related to a lack of acetylcholine, a substance responsible for sending messages between brain cells. Reminyl works by increasing the amount of acetylcholine in the brain and so improves the symptoms of the disease.

WHEN REMINYL SHOULD NOT BE USED

Reminyl should not be taken:
By people who have had an allergic reaction to galantamine (Reminyl) or to any of the other ingredients. Check the ingredients by reading the section above called 'What is Reminyl'. An allergic reaction may be recognized as a rash, itching, swollen face or lips, or shortness of breath- By people who have either severe liver or severe kidney disease. By people who have significant, combined liver and kidney problems. Speak to your doctor if you suffer from these problems or have suffered from them in the past.

BEFORE TAKING REMINYL

Medicines are not always suitable for everyone. Do you have any of the following conditions? Have you suffered from these in the past? Liver or kidney problems; Heart disorders; Stomach ulcer or duodenal ulcer; Acute abdominal pain; Epilepsy; Respiratory diseases that affect breathing (like asthma); A recent operation on the gut or bladder or difficulties in passing urine; Galactose intolerance, lactase deficiency or glucose-galactose malabsorption. As Reminyl contains lactose it may not be suitable for you.

If the answer to any of these questions is 'Yes', speak to your doctor for advice before any Reminyl is taken. Your doctor will decide whether this medicine is suitable for you. Your doctor may adjust the amount of medicine that you take.

If you are pregnant, trying to become pregnant or breast-feeding, do not take any Reminyl before speaking to your doctor for advice. If you need to have a general anesthetic for an operation, tell the doctor that Reminyl is being taken. Reminyl is not recommended for children.

Reminyl is not recommended for driving or operating machinery (Reminyl, as well as the disease itself, can affect the ability to drive or operate machinery. Please discuss this with your doctor).

OTHER MEDICINES

Always tell the doctor; nurse or pharmacist if any other medicines are being taken because taking some medicines together can be harmful.

Reminyl should not be taken with other medicines that act the same way. If medicines for diarrhea, Parkinson's disease or asthma are taken, check with your doctor to see if these affect Reminyl. Tell your doctor if drugs for certain heart disorders or high blood pressure (e.g. digoxin or the so-called beta-blockers) are being taken. Your doctor may prescribe a smaller dose of Reminyl if certain drugs are being taken at the same time (for example certain antidepressants (such as paroxetine, fluoxetine or fluvoxamine), quinidine (used for heart rhythm problems), ketoconazole (an antifungal or ritonavir (a treatment for HIV).

If you are not sure, speak to your doctor or pharmacist for advice.

HOW TO TAKE REMINYL

Reminyl should be taken by mouth. It should be taken twice a day, preferably with morning and evening meals.

Reminyl is usually started at a low dose. Your doctor may then slowly increase the amount of Reminyl that you take to find the most suitable dose for you.

Treatment with Reminyl is usually started at a dose of 4 mg taken twice daily. This dose will be taken for at least four weeks. Your doctor will then increase the dose to 8mg taken twice daily. This dose will be taken for at least 4 weeks. If your doctor decides to increase your dose again, you should take 12 mg twice daily.

What if a dose of Reminyl is forgotten?

If a dose is missed, the next dose should be taken as usual. Then continue as before. If more than one dose has been missed, contact your doctor for advice. Do not take 2 doses at the same time to make up for a missed dose.

OVERDOSE

If too much Reminyl has been taken, contact a doctor or hospital straightaway. Take any remaining tablets and the packaging with you.

AFTER TAKING THIS MEDICINE

If undesired effects such as nausea and vomiting occur, they are mainly experienced early on in the treatment or when the dose is increased. They tend to disappear gradually as the body gets used to the treatment and generally will not last for more than a few days. If you are experiencing these effects your doctor may recommend that you drink more liquids and, if necessary, they may prescribe medicine to stop you being sick.

Other possible side effects include: abdominal pain, diarrhea, indigestion, decreased appetite and weight loss. Also, headache, dizziness, tiredness, sleepiness or sleeplessness and confusion might be experienced as well as a runny or blocked nose, a urinary tract infection and falling, sometimes resulting in injury.

In very rare cases trembling has occurred. A slow heartbeat or fainting has also been reported. Should such symptoms be experienced, contact a doctor as medical assistance might be necessary.

Do not be alarmed by this list of possible side effects. You may not have any of them. Tell your doctor or pharmacist if you are worried or think that Reminyl is causing you any problem.

HOW TO STORE REMINYL

As with all medicines, Reminyl should be kept in a safe place where children cannot see or reach it. There are no special storage instructions for Reminyl tablets. Medicines can be kept for a limited period only. Therefore, do not use Reminyl after the date printed on the packaging. Always return any leftover medicines to your pharmacist.

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