Patient leaflet - Lagap Migraine Relief tablets
1. WHAT ARE MIGRAINE RELIEF TABLETS AND WHAT ARE THEY USED FOR?
These tablets contain aspirin which is a type of painkiller and belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs) and cyclizine which is a type of antihistamine which can be used to prevent you feeling sick (nausea) or being sick (vomiting). Migraine Relief Tablets are used to relieve pain resulting from migraine/headache and to help prevent any nausea and vomiting which can occur with migraines.
2. BEFORE YOU TAKE MIGRAINE RELIEF TABLETS
Do not take these tablets if you:
- Are allergic (hypersensitive) to Aspirin, any other salicylates or any of the other ingredients of this medicine (listed in section 6).
- Have had an allergic reaction to Cyclizine (symptoms of mild allergic reaction include: itching and or rash (mild); symptoms of a severe allergic reaction include: swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing).
- Have a history of hypersensitivity reactions (eg asthma, rhinitis, urticaria) induced by pain relieving or anti-inflammatory medicines (eg NSAIDs or salicylates).
- Have severe liver or kidney problems.
- Have severe heart problems.
- Have a stomach or duodenal ulcer or have had problems with ulcers in the past.
- Suffer from haemophilia or any other excessive bleeding condition.
- Are on a high dose of methotrexate (15mg per week or more). If you are not sure, check with your doctor. Also see section ‘Using other medicines.’
- Are pregnant or breast feeding, unless advised by a doctor.
Warning and precautions:
Take special care and tell your doctor before taking Migraine Relief tablets if you:
- Are allergic (hypersensitive) to any other pain relieving, anti-rheumatic or anti-inflammatory medicines eg NSAIDs (see section 4 possible side effects).
- Have asthma or suffer from tightness in the chest.
- Have low uric acid excretion, which is commonly associated with gout.
- Have a history of gastrointestinal disorders (regular stomach upsets; chronic constipation).
- Have been told you are deficient in glucose-6-phosphate dehydrogenase (G6PD), as you may experience anaemia.
- Have kidney, liver, heart or blood circulation problems.
- Are about to have surgery. Before the operation tell the doctor or surgeon that you are taking aspirin.
- Have an eye disease caused by raised pressure within the eye (glaucoma).
- Are male and suffer from an enlarged prostate gland (difficulty or slowness passing urine).
- Have epilepsy.
- Suffer from an inherited disorder which can lead to a sensitivity to light (porphyria).
- Have a drug addiction.
If you are not sure whether any of the above apply to you, speak to a doctor or pharmacist before taking this medicine.
Children and adolescents:
Do not give this medicine to children under the age of 16 unless your doctor tells you. This is because there is a possible association between Aspirin and Reye’s syndrome when given to children. Reye’s syndrome is a very rare disease, which can be fatal.
Other medicines and Migraine Relief Tablets:
Tell your doctor or pharmacist if you are already taking or have recently taken any of the following medicines, including medicines obtained without a prescription as their effectiveness may be influenced by aspirin if taken at the same time.
- Medication to lower blood sugar if you are diabetic.
- Blood thinning medicines such as heparin, warfarin or ticlopidine.
- Medication to treat Addison’s disease e.g. corticosteroids except hydrocortisone.
- Corticosteroids e.g. hydrocortisone (which can be used for arthritis, asthma and inflammatory conditions).
- Any pain relieving or anti-inflammatory medicines for pain and inflammation e.g. ibuprofen or strong pain killers such as pethidine.
- Medicines to treat heart problems or to lower High blood pressure: digoxin, Angio-ll receptor antagonists or ACE inhibitors.
- Diuretics to treat water retention.
- Epilepsy medicines e.g. phenytoin, sodium valproate.
- Methotrexate (for psoriasis, rheumatoid arthritis, Crohn’s disease or some types of cancer).
- Antacids for indigestion.
- Gout medications e.g. probenecid or sulphinpyrazone.
- Medicines used to treat depression, anxiety or difficulty sleeping, including SSRIs, hypnotics or tranquilisers.
- Any anticholinergic medicine to treat urinary incontinence, irritable bowel syndrome and Parkinson’s disease.
Taking Migraine Relief Tablets with food and drink:
Avoid taking alcohol while taking Migraine Relief Tablets.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking this medicine. Migraine Relief tablets should not be taken if you are pregnant or if you are trying for a baby, unless directed by your doctor. Do not take this medicine if you are breast-feeding. Aspirin can prolong labour and affect blood clotting in the mother or baby.
Driving and using machines
You can drive while taking Migraine Relief tablets, but do not drive until you know how these tablets affect you. Migraine Relief tablets may make you feel drowsy. If they affect you in this way, do not drive or operate any machinery.
3. HOW TO TAKE MIGRAINE RELIEF TABLETS
Following these dosing instructions carefully. If you are unsure how to take these tablets discuss it with your doctor or pharmacist first before starting treatment.
Dosage in adults, the elderly and children over the age of 16 years:
Take two (2) tablets with water at the onset of or the first sign of symptoms. Two (2) more tablets may be taken after 4 hours if required. Do not take more than 8 tablets in any 24 hours.
- Do not give to children aged under 16 years unless told to by your doctor.
- Do not exceed the stated dose.
- Seek medical attention IMMEDIATELY if you accidentally take too many tablets. Take this leaflet and any packaging with you to show what you have taken.
- If you forget to take a dose, do not take a double dose to make up for the missed dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines Migraine Relief Tablets can cause side effects, although not everyone gets them.
If you get any of the following side effects, stop taking the tablets immediately. See a doctor or go to your nearest Accident and Emergency Department at once:
- Stomach ulcer or perforation, stomach bleeding, which may result in passing blood in your stools presenting as black tarry stools, nausea, diarrhoea, vomiting.
- Mild stomach problems including pain, indigestion or heartburn. These are the most common side effects but can usually be avoided if aspirin is taken with food.
- Allergic reactions. Signs of these include: skin rashes or itching, large or itchy wheals on the skin, attacks of sneezing, runny nose and itching eyes or water retention, swelling of the face, lips, tongue or throat, difficulty in breathing or swallowing, wheeziness.
- Skin reddening, blistering of lips, eyes or mouth, skin peeling.
- Increased bleeding time/blood thinning when you cut or injure including, bleeding under the skin which may look like bruising, nose bleeds, bleeding gums.
- Internal bleeding which may result in anaemia causing weakness, increased tiredness and pale skin.
- Hearing problems (e.g., ringing in the ears) or feeling dizzy.
- An asthma attack if you are asthmatic and sensitive to aspirin, breathing difficulties (bronchospasm).
- Changes in normal liver activity in blood tests (very rare).
- Runny nose, blocked nose.
- Kidney problems.
- Unpleasant sensation or an overwhelming urge to move the legs (also called Restless Legs Syndrome).
Other side effects include:
- Skin rashes or itching
- Drowsiness
- Headache
- Dry mouth, nose or throat
- Blurred vision
- Rapid heartbeat
- Difficulty in passing urine
- Constipation
- Restlessness
- Nervousness
- Difficulty in sleeping
- Seeing or hearing things that are not really there (hallucinations)
- Decrease in muscle tone that can cause irregular body movements
- Unusual body movements, particularly of the hands, arms or legs
- Muscle twitches, spasms or tremors
- Fits (seizures)
- Confusion, feeling disorientated or dizziness
- Decreased consciousness/ loss of consciousness
- Temporary difficulty in speaking
- High blood pressure
- Pins and needles
- Yellowing of the skin and the whites of the eyes (jaundice)
- A red or brownish patch which appears at the same spot each time you take this medicine
- Inflammation of the liver (hepatitis) or problems with the liver
- Reduced rate of breathing (apnoea)
- Reduction in the production of a type of white blood cell making infection more likely (agranulocytosis).
If you feel very tired, experience unexplained bruising or bleeding or more infections (e.g., colds and sore throats) than usual, please tell your doctor. Your doctor may decide to carry out tests on your blood as a result of these symptoms.
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 MIGRAINE RELIEF TABLETS
Keep your medicine out of the sight and reach of children.
Do not store above 25°C.
Store in the original packaging to protect from light and moisture.
Do not use this medicine after the expiry date printed on the packaging. The expiry date refers to the last date of that month.
Do not use this medicine if you notice a tablet is powdery or discoloured.
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. FURTHER INFORMATION
What Migraine Relief Tablets contains
The active ingredients in these tablets are aspirin (acetylsalicylic acid) 500mg and cyclizine 25mg.
The other excipients are Mannitol, Polyvinylpyrrolidone, Malic Acid, Sodium Dioctyl Sulphosuccinate, Sodium Bicarbonate, Citric Acid (Anhydrous), Dextrates (Anhydrous), Sodium Carbonate (Anhydrous), Saccharin Sodium and Lemon Permaseal.
What Migraine Relief Tablets looks like and contents of the pack
Migraine Relief tablets are available in polythene coated foil ‘Strip Packs’
Foil strips of 4 or 6 in a cardboard carton. Pack sizes: 4, 12, 16, 18, 24 and 48.
The marketing authorisation holder and manufacturer is
Aspar Pharmaceuticals Ltd,
Albany House, Acrewood Way,
St Albans, AL4 0JY
PL 08977/0036
Date of leaflet revision: March 2021