Patient leaflet - Trolactin 200 mg prolonged-release hard capsules
1. What Trolactin is and what it is used for
Trolactin contains the active substance dipyridamole. This belongs to a group of medicines called ‘anti-thrombotic agents’, which are used to stop blood clots forming.
Trolactin is used:
- To reduce the risk of having another stroke in people who have had a stroke caused by a blood clot in the brain.
2. What you need to know before you take Trolactin
Do not take Trolactin:
- if you are allergic to dipyridamole or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Trolactin:
- If you have angina or other heart diseases or have had a recent heart attack
- If you have myasthenia gravis (muscle weakness)
- If you have any bleeding problems.
If you are having heart tests
Trolactin contains dipyridamole. Dipyridamole is also sometimes given as an injection during tests to see if the heart is working properly (also called ‘myocardial imaging’). This means that the test and your medicine may contain the same substance. If you are going to have an injection of dipyridamole, tell the doctor that you are taking Trolactin.
Children and adolescents
Trolactin should not be given to children since the safety and efficacy has not been established.
Other medicines and Trolactin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes herbal medicines. This is because Trolactin can affect the way some other medicines work. Also some other medicines can affect the way Trolactin works.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
- Medicines for high blood pressure
- Medicines for muscle weakness (myasthenia gravis), called a ‘cholinesterase inhibitor’
- Adenosine, used for heart problems or tests on the heart
- Warfarin, acetylsalicylic acid or other medicines to stop blood clots forming
- Theophylline (a medicine for respiratory problems).
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Trolactin should generally not be used in pregnancy.
Trolactin should only be used during breast-feeding if your doctor considers it essential, since dipyridamole is excreted in breastmilk.
Driving and using machines
You may feel dizzy while taking Trolactin. If this happens do not drive or use any tools or machines.
3. How to take Trolactin
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one capsule twice a day, usually one in the morning and one in the evening.
The capsules may be taken with or without food.
Swallow the capsule whole. Do not crush or chew it.
If you take more Trolactin than you should
If you take more of this medicine than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you, even if there are no capsules left.
Symptoms such as feeling warm, flushes, sweating, faster pulse, restlessness, feeling of weakness, dizziness, drop in blood pressure and chest pain can be expected.
If you forget to take Trolactin
If you forget a dose, take it as soon as you remember it. However, if it is time for the next dose, skip the missed dose.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Trolactin
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions
If you have an allergic reaction, stop taking your medicine and see a doctor straight away. The signs may include feeling breathless, runny nose, severe rash with itching, swelling and swelling around the eyes.
Other side effects that have been reported for Trolactin are described below.
Very common (may affect more than 1 in 10 people)
- Headache
- Feeling dizzy
- Feeling sick (nausea)
- Diarrhoea.
Common (may affect up to 1 in 10 people)
- Muscle pain
- Being sick (vomiting)
- Rash
- Worsening of the symptoms of heart disease such as chest pain and shortness of breath.
Not known (frequency cannot be estimated from the available data)
- Hot flushes
- Lowering of blood pressure or increased heart rate
- A blood problem called ‘thrombo-cytopenia’ which can cause bruising and prolonged bleeding from wounds, including during or after surgery.
In people who have gallstones, the dipyridamole in this medicine can be absorbed into the gallstones.
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 Website: 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 Trolactin
Keep this medicine out of the sight and reach of children.
Store in the original package in order to protect from moisture. Keep the bottle tightly closed.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.
Shelf life after first opening: 100 days.
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. Contents of the pack and other information
What Trolactin contains
The active substance is dipyridamole. Each prolonged-release capsule contains dipyridamole
200mg. Trolactin is a prolonged-release capsule which releases the active substance slowly in your body over a number of hours.
- The other ingredients are: Capsule content: Tartaric acid, hypromellose, talc, hydroxypropyl cellulose, methacrylic acid – methyl methacrylate copolymer (1:2), triethyl citrate. Capsule shell: Gelatin, titanium dioxide (E171) and red iron oxide (E172).
What Trolactin looks like and contents of the pack
Trolactin 200mg Prolonged-release Hard Capsules are reddish-brown (orange) hard capsules, 23.5mm.
Trolactin is available in packs of 60 capsules.
Marketing Authorisation Holder
Accord Healthcare Limited
Sage House
319 Pinner Road
North Harrow
Middlesex
HA1 4HF
United Kingdom
Manufacturer
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
2600 Dupnitsa
Bulgaria
This leaflet was last revised in April 2018.
If you would like a leaflet with larger text, please contact
01271 385257.
Pil Spec no
Accord Healthcare Ltd, North Harrow, HA1 4HF, UK