Active ingredient
- labetalol hydrochloride
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 36301/0014.
Trandate 50mg, 100mg, 200mg and 400mg Film-coated Tablets
Patient Information Leaflet:
Trandate 50mg film-coated Tablets, Trandate 100mg film-coated Tablets,Trandate 200mg film-coated Tablets and Trandate 400mg film-coated Tablets
Labetalol hydrochloride
Read all of this leaflet carefully before you start taking this medicine.
In this leaflet:
1. What Trandate is for
2. Before you take Trandate
3. How to take Trandate
4. Possible side effects
5. How to store Trandate
6. Further information
1. What Trandate is for
Trandate belongs to a group of medicines called beta blockers.
Trandate works by causing the heart to beat more slowly and with less force. It also widens the arteries in the body. This helps to lower the pressure of the blood as it travels around the body. The result is a lower blood pressure and the prevention of angina (chest pain).
Trandate are used to treat:
High blood pressure often causes no obvious symptoms but if it is not treated it can damage blood vessels in the long-term. This can lead to heart attacks, kidney failure, stroke or blindness. This is why it is important not to stop taking this medicine without talking to your doctor.
2. Before you take Trandate
Do not take Trandate if:
If any of the above applies to you, talk to your doctor.
Check with your doctor before taking Trandate if:
Tell your doctor if you are taking any of the following medicines
Taking Trandate at the same time as the drugs mentioned for treating your heart or blood pressure can lead to a severe drop in blood pressure, reduced heart rate, heart failure or heart block. It is important to tell your doctor if you are taking these or any of the other drugs listed above.
The results of blood or urine tests may be affected by taking Trandate. If you need to have a blood or urine test, tell your doctor that you have been given Trandate tablet.
Taking Trandate with food and drink
Always take your tablets with food. As a safety precaution it is recommended to avoid alcohol.
Pregnancy and breast-feeding
Trandate should only be used during the first 3 months of pregnancy if it is absolutely necessary. Therefore tell your doctor if you are pregnant or trying to become pregnant.
Trandate is not recommended whilst breast feeding.
Driving and using machines
You may feel dizzy or tired when taking Trandate. If this happens to you, do not drive or operate machinery.
Warnings about the ingredients in Trandate
Trandate contains sodium benzoate which is a mild irritant to the eyes, nose and mucous membranes. It may increase the risk of jaundice in new born babies. If you think this medicine has upset you (or your baby) in any way, please tell your doctor as soon as possible.
Trandate contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Trandate tablets
Always take Trandate exactly as your doctor has told you to.
IMPORTANT:
Your doctor will choose the dose that is right for you. Your dose will be shown clearly on the label that your pharmacist puts on your medicine. If it does not, or you are not sure, ask your doctor or pharmacist.
Remember: Your tablets should be swallowed whole and should be taken with food.
Adults:
High blood pressure, with or without angina
High blood pressure during pregnancy
Elderly:
Children: Trandate is not recommended for children.
If you take more Trandate than you should
Do not take more Trandate than you should. If you take too many tablets tell your doctor immediately or contact your nearest hospital emergency department. You should take your tablets with you if possible.
If you forget to take Trandate
Do not take a double dose to make up for a missed dose. Simply take the next dose as planned.
If you stop taking Trandate
Do not stop taking Trandate suddenly. Continue taking them until your doctor tells you to stop. He or she will gradually reduce the dose over a few weeks if necessary.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines Trandate can cause side effects, although not everybody gets them.
Stop using Trandate and seek immediate medical help if you have an allergic reaction.
This includes any of the following symptoms:
Most of the side effects related to Trandate will wear-off after the first few weeks.
These include:
If any of these side effects occur, speak to your doctor immediately.
Other side effects that may occur include:
Rare side effects on your baby
If you are being treated for high blood pressure during pregnancy your baby may suffer the following effects for a few days after birth:
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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard, or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Trandate
Keep this medicine out of the sight and reach of children.
Do not use Trandate after the expiry date which is shown on the carton label, blister foil and container label after EXP. The expiry date refers to the last day of that month.
No special storage conditions are necessary.
Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist.
6. Further Information
What Trandate contains
The active ingredient is labetalol hydrochloride. The tablets contain either 50mg, 100mg, 200mg or 400mg of the active ingredient.
The other ingredients are: In the tablet core: lactose monohydrate, magnesium stearate (E572), starch maize. In the film coating: hypromellose (E464), sodium benzoate (E211), titanium dioxide (E171), sunset yellow (E110), methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), industrial methylated spirit and purified water.
What Trandate looks like
The tablets are orange with either ‘Trandate 50’, ‘Trandate 100’, ‘Trandate 200’ or ‘Trandate 400’ written on one side. Trandate 50mg tablets come in packs containing 56 tablets. Trandate 100mg, Trandate 200mg and Trandate 400mg tablets come in packs containing 56 or 250 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised in November 2019.
If this leaflet is difficult to see or read or you would like it in a different format, please contact
PET004355-UK
Lagervagen 7, Jordbro, Sweden
+44 (0)845 023 0467
+44 207 862 1716
+44(0)845 023 0467
+44(0)845 023 0467