Reminyl 12mg Tablets
Out of date information, search anotherReminyl Tablets 8mg/
Reminyl 12mg Tablets
(galantamine hydrobomide)
This product is available in the above two strengths but will be referred to as Reminyl Tablets throughout the following;
Patient Information Leaflet
Please read this information leaflet about Reminyl Tablets carefully before you start taking your tablets. It contains all the information you should need to know. If you have any further questions or are not sure about anything, ask your doctor or pharmacist. Please keep this leaflet in a safe place, you may wish to refer to it again.
The name of this medicine is Reminyl Tablets.
The active ingredient is galantamine hydrobomide.
Reminyl Tablets are available as:
Reminyl Tablets 8 mg: contain 10.254 mg galantamine hydrobromide equivalent to 8mg galantamine in a pink round, biconvex, film-coated tablet marked 'JANSSEN' on one side and on the reverse side ‘GB’ with a breakline.
Reminyl 12mg Tablets: contain 15.380mg galantamine hydrobromide equivalent to 12mg galantamine in an orange round film-coated tablet marked ‘JANSSEN’ on one side and ‘G12’ on the reverse. White core.
The tablets also contain the following inactive ingredients: colloidal anhydrous silica, crospovidone, hypromellose, lactose monohydrate, magnesium sterate, microcrystalline cellulose, propylene glycol, talc, titanium dioxide (E171) and red ferric oxide (E172).
Additionally, the 12mg tablet contains orange yellow S aluminium lake (E110)
The tablets are available in calendar blister packs containing 56 tablets.
POM| PL No: 17367/0543 Reminyl Tablets 8mg
PL No: 30984/0229 Reminyl 12mg Tablets
This product is manufactured by Janssen-Cilag S.p.A., Via C. Janssen, Borgo San Michele, 04010 Latina, Italy and is procured from within the EC. by the Product Licence holder: S.C.A.C. Ltd., unit 2a Bandeath Industrial Estate, Throsk, Stirling, FK7 7NP.
Why you need this medicine:
Reminyl Tablets are used to treat the symptoms of mild to moderately severe dementia of the Alzheimer type, a disease that alters the brain function.
The symptoms include progressive memory loss, increasing confusion and behavioural changes. As a result, sufferers find it becomes more and more difficult to carry out their normal daily activities.
Symptoms of dementia of the Alzheimer type are believed to be related to a lack of acetylcholine, a substance responsible for sending messages between brain cells. Reminyl Tablets work by increasing the amount of acetycholine in the brain and so improves the symptoms of the disease.
Before you take your medicine:
Make sure it is safe for you to take Reminyl Tablets.
Reminyl Tablets 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 in this pack. An allergic reaction may be recognised 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.
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 malabsorbtion. As Reminyl Tablets contain lactose it may not be suitable to you.
If the answer to any of these questions is ‘Yes’, speak to your doctor for advise before any Reminyl Tablets are taken.
Your doctor will decide whether this medicine is suitable for you. Your doctor will adjust the amount of medicine that you take.
If you are pregnant, trying to become pregnant or breastfeeding, do not take any Reminy Tablets before speaking to your doctor for advice.
If you need to have a general anesthetic for an operation, tell the doctor that Reminyl Tablets are being taken.
Reminyl Tablets are not recommended for children.
Precautions and Warnings
The colouring orange yellow S aluminium lake (E110) in the 12mg tablets can cause an allergic reaction, like asthma, in some people. An allergic reaction to orange yellow S aluminium lake (E110) is more likely in people who are allergic to aspirin (acetylsalicylic acid). Speak to your doctor for advice before taking any tablets.
Reminyl Tablets, 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 Tablets should not be taken with other medicines that act the same way. If medicines for diarrhoea, Parkison’s disease or asthma are taken, check with your doctor to see if these affects Reminyl Tablets.
Tell your doctor if drugs of 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 Tablets if certain drugs are being taken at the same time (for example 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 use your medicine
Reminyl Tablets should be taken by mouth. It should be taken twice a day, preferably with morning and evening meals.
Reminyl Tablets are usally started at a low dose. Your doctor may then slowly increase the amount of Reminyl Tablets that you take to find the most suitable dose for you. Treatment with Reminyl Tablets 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 8 mg 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 to do if an overdose is taken
If too many Reminyl Tablets are taken, contact your doctor or hospital straightaway. Take any remaining tablets and the packaging with you.
What to do if you miss a dose
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.
Side Effects:
If undesired effects such as nausea and vomiting occur, they are mainly experienced early on in 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 a medicine to stop you being sick.
Other possible side effects include: abdominal pain, diarrhoea, 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 inection and falling, sometimes resulting in injury.
In very rare cases trembling has occurred. A slow heatbeat 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 you doctor or pharmacist if you are worried or think that Reminyl Tablets are causing you any problems.
Expiry Date:
Do not take any tablets after the expiry date printed on the carton label or blister strip.
IMPORTANT:
This medicine is for YOUR use only. It can only be prescribed by a doctor. Never give it to anyone else. It may harm them even if their symptoms are the same as yours.
This leaflet does not contain complete information about your medicine. If you have any questions, or are not sure about anything, ask your doctor or pharmacist who has access to additional information.
Leaflet revision and issue date 25.03.14 DIH 2157
Storage:
There are no special storage instructions for Reminyl Tablets.
KEEP OUT OF THE REACH OF CHILDREN.
If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe diposal. Only keep the tablets if your doctor tells you to.
If the tablets become discoloured or show any other signs of deteriation, you should seek the advise of your pharmacist who will advise you what to do.