Stimlor
STIMLOR 100 mg CAPSULES Naftidrofuryl Oxalate
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass it on to others. It may harm them, even if their symptoms 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.
IN THIS LEAFLET:
1. What Stimlor is and what it is used for
2. Before you take Stimlor
3. How to take Stimlor
4. Possible side effects
5. How to store Stimlor
6. Further information
1. WHAT STIMLOR IS AND WHAT IT IS USED FOR
• Stimlor belongs to a group of drugs called vasodilators. These act by causing the opening out of blood vessel walls and are used in certain disorders of blood circulation
• Stimlor is used:
• to treat mental insufficiency and confusion by improving blood circulation
• to treat disorders of blood circulation in the limbs which cause rest pain, night cramps, cramp like pain in the calves brought on by exercise and early stages of gangrene
• to treat Raynaud's syndrome by increasing blood circulation, (a condition where there is poor blood circulation which makes the toes and fingers pale and numb)
• to treat diseases of the arteries and acrocyanosis (blue/red discoloration of the skin of the fingers, wrists and ankles)
• open sores on the legs or feet (trophic ulcers)
• poor circulation caused by diabetes (diabetic arteriopathy).
2. BEFORE YOU TAKE STIMLOR
Do NOT take Stimlor if you:
• are allergic (hypersensitive) to naftidrofuryl oxalate or any of the ingredients in your medicine
• have had kidney stones or other urinary problems in the past.
THIS MEDICINE IS NOT RECOMMENDED FOR CHILDREN.
Take special care with Stimlor
Whilst taking Stimlor, you should drink plenty of fluids. This will help to prevent the formation of kidney stones.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
If you are pregnant, planning to become pregnant or breast-feeding ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Stimlor is not known to affect your ability to drive or operate machinery.
Important information about some of the ingredients of Stimlor
Azorubine (E122) contained within the capsule shell may cause allergic reactions including asthma; this reaction is more common in those people that are allergic to aspirin.
3. HOW TO TAKE STIMLOR
The capsules should be swallowed whole, do not chew them., Always take your capsules with a large glass of water. The administration of Stimlor capsule without liquid before going to bed may cause inflamation in throat. Stimlor should be taken with food.
Always take Stimlor exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is:
Adults including the elderly
• Cerebral vascular disorders (affecting the blood supply to the brain)
100 mg three times a day for a minimum period of three months, your doctor may alter your dose as necessary.
• Peripheral vascular disorders (affecting the blood supply to the arms and legs)
100 mg to 200 mg taken three times a day for a minimum period of three months, your doctor may alter your dose as necessary.
Children
Stimlor is not recommended for use in children.
Do not stop taking Stimlor unless your doctor tells you to, even if you feel better.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you take more Stimlor than you should
If you (or someone else) swallow a lot of the capsules all together, or if you think a child has swallowed any of the capsules, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause fits and heart problems. Please take this leaflet, any remaining capsules and the container with you to the hospital or doctor so that they know which capsules were consumed.
If you forget to take Stimlor
Do not take a double dose to make up for a forgotten dose, take one as soon as you remember, unless it is nearly time to take the next one, then take the remaining doses at the correct time.
4. POSSIBLE SIDE EFFECTS
With the recommended dosage schedule Stimlor is normally well tolerated .but like all medicines, Stimlor can cause side effects, although not everybody gets them.
If the following happens, STOP taking the capsules and tell your doctor immediately or go to the casualty department at your nearest hospital:
• an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives).
• liver disorder which may include hepatitis, which is inflammation of the liver, causing yellowing of the skin and eyes.
These are very serious but rare side effects. You may need urgent medical attention or hospitalisation.
Other side effects may include:
Uncommon (affects 1 to 10 users in 1,000):
• stomach pain
• feeling sick (nausea)
• diarrhoea
• vomiting
Frequency not known (frequency cannot be estimated from the available data)
• inflammation of the gullet
very rare (affects less than 1 user in 10,000):
• occurrence of kidney stones.
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 STIMLOR
Keep out of the reach and sight of children.
Store in the original package, below 25°C. Do not use Stimlor after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month. 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.
6. FURTHER INFORMATION
What Stimlor capsules contain:
• The active ingredient is naftidrofuryl oxalate 100 mg
• The other ingredients are maize starch, povidone (E1201), sodium lauryl sulphate, talc (E553(b)), sodium starch glycolate, colloidal silicon dioxide(E551), magnesium stearate (E572) and stearic acid (E570). The capsules are made of gelatin and contain the colours azorubine (E122) and titanium dioxide (E171), the printing ink contains shellac (E904), the colour black iron oxide (E172) and propylene glycol (E1520).
What Stimlor capsules look like and contents of the pack:
• Stimlor capsules are hard rose coloured capsules containing a white powder and overprinted 2N1.
• Stimlor capsules are packed in HDPE or polypropylene containers with caps or child resistant closures in packs of 28, 30, 50, 56, 60, 90, 100, 250, 500, or 1000 capsules. Blister strips in packs of 10, 28, 30, 56, 84, 90, 100 or 500 capsules.
Glass jars with screw cap containing 90, 100 or 500 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder and company responsible for manufacture: TEVA UK Limited, Brampton Road, Hampden Park, Eastbourne, BN22 9AG.