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Baratol Tablets 25mg

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Patient Information Leaflet 726-3916-APIL


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AMDIPHARM

Baratol* Tablets 25 mg

Read all of this leaflet carefully before you are given 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 any of the side effects becomes severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Baratol Tablets are and what they are used for

2.    Before you take Baratol Tablets

3.    How to take Baratol Tablets

4.    Possible side effects

5.    How to store Baratol Tablets

6.    Further information

1.    WHAT BARATOL TABLETS ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Baratol Tablets. Baratol Tablets contain the active ingredients Indoramin Hydrochloride which belong to a group of medicines called alpha-adrenoreceptor blockers.

Baratol Tablets are used to reduce high blood pressure.

2.    BEFORE YOU TAKE BARATOL TABLETS

Do not take Baratol Tablets if you: are allergic (hypersensitive) to Indoramin hydrochloride or any of the other ingredients in Baratol Tablets;

•    have heart failure;

•    are currently taking a medicine called a monoamine oxidase inhibitor (MAOIs)

(used to treat depression).

Take special care with Baratol Tablets if you:

•    have any liver or kidney problems;

•    have Parkinson’s disease;

•    have epilepsy;

•    have or have ever suffered from depression.

If any of these apply to you, or if you are not sure, tell your doctor before taking Baratol Tablets.

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.

This is especially important if you are taking;

•    any antidepressants, especially monoamine oxidase inhibitors (MAOIs) (e.g. phenelzine, tranylcypromine);

•    any medicines to treat high blood pressure, especially beta-blockers (e.g. propanolol, pindolol) or calcium channel blockers (e.g. diltiazem, nifedipine, verapamil);

•    any diuretics (e.g. bendroflumethiazide, furosemide).

Pregnancy and breast-feeding

If you are pregnant, thinking of becoming pregnant or you are breast-feeding, please talk to you doctor before taking Baratol Tablets.

Taking Baratol Tablets with Food and Drink

Do not drink alcohol while taking Baratol Tablets, as it can increase the effect of your medicine and increase any drowsiness you may feel.

Driving and using machines

You can drive while taking Baratol Tablets but do not drive until you know how the tablets affect you. They may make you feel drowsy, especially at the start of treatment or when increasing the dose. If they affect you in this way, do not drive or operate any machinery.

Important information about some of the ingredients of Baratol Tablets

Baratol Tablets contain lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3.    HOW TO TAKE BARATOL TABLETS

Always take Baratol Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Your doctor will start you at a low dose of 25 mg twice daily and gradually increase it, if necessary, until your blood pressure is under control.

The usual dose varies between 50 mg and 200 mg daily divided into 2 or 3 doses.

The tablets should be swallowed with a glass of water.

Elderly patients may not require as much as other patients and may be given a smaller dose or less frequent dosing.

If you take more Baratol Tablets than you should

If you take more Baratol Tablets than you should, contact your doctor or nearest hospital emergency department immediately. Take the container and any remaining tablets with you.

If you forget to take Baratol Tablets

If you forget to take Baratol Tablets take the next dose as soon as you remember, unless it is nearly time for your next dose. Do not take a double dose to make up for the forgotten dose.

4.    POSSIBLE SIDE EFFECTS

Like all medicines Baratol Tablets can cause side effects, although not everybody gets them.

If you notice;

•    Itching or skin rashes;

•    Swelling of your face, lips or throat;

•    Difficulty in breathing or wheeziness.

Stop taking the medicine and seek medical advice immediately. These may be signs of an allergic reaction.

Other side effects of Baratol Tablets may include:

•    palpitations;

•    diarrhoea;

•    dry mouth, headache, nasal congestion;

•    feeling sick, dizziness;

O

AMDIPHARM


•    weakness, lack of energy, drowsiness, sleepiness;

•    weight gain;

•    depression;

•    low blood pressure, especially when standing up;

•    increased need to pass water, uncontrolled passing of water (incontinence);

•    ejaculation failure, prolonged painful erection in men.

If any of the side effects becomes severe, or if you notice any side effect not listed in this leaflet, please tell your doctor.

5.    HOW TO STORE BARATOL TABLETS

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.

Do not use after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.

Store your medicine in a dry place below 25°C. Keep it out of direct sunlight.

6.    FURTHER INFORMATION

What Baratol Tablets contain

The active ingredient is 25 mg Indoramin Hydrochloride. The other ingredients are amberlite IRP 88, Avicel PH 101, lactose and magnesium stearate. The coating material contains hydroxypropylmethyl cellulose 2010, polyethylene glycol 400 and opaspray M-1-20972.

What Baratol Tablets look like and contents of the pack

Baratol Tablets are round, blue tablets with ‘MPL 020’ imprinted on one side and ‘25’ on the other face. Baratol Tablets are available in amber glass bottles, aluminium/polyethylene foil strip and securitainers containing 10, 28, 56, 84,100 or 112 tablets.

Marketing Authorisation Holder and Manufacturer responsible for release:

Amdipharm Pic t/a Amdipharm,

Regency House,

Miles Gray Road,

Basildon,

Essex SS14 3AE

*Trade Mark

Date of preparation: June 2008