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Patient Information Leaflet 726-3973-APIL

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 foryou. 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 Indoramin Hydrochloride 25 mg Tablets are and what they are used for

2.    Before you take Indoramin Hydrochloride 25 mg Tablets

3.    Howto take Indoramin Hydrochloride 25 mg Tablets

4.    Possible side effects

5.    Howto store Indoramin Hydrochloride 25 mg Tablets

6.    Further information

1.    WHAT INDORAMIN HYDROCHLORIDE 25 MG TABLETS ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Indoramin Hydrochloride 25 mg Tablets. Indoramin Hydrochloride 25 mg Tablets contain the active ingredients Indoramin Hydrochloride which belongs to a group of medicines called alpha-adrenoreceptor blockers.

Indoramin Hydrochloride 25 mg Tablets are used fo reduce high blood pressure.

2.    BEFORE YOU TAKE INDORAMIN HYDROCHLORIDE 25 MG TABLETS

Do not take Indoramin Hydrochloride 25 mg Tablets If you:

•    are allergic (hypersensitive) to Indoramin hydrochloride or any of the other ingredients in Indoramin Hydrochloride 25 mg Tablets;

•    have heart failure;

•    are currently taking a medicine called a monoamine oxidase inhibitor (MAOIs) (used to treat depression).

Take special care with

Indoramin Hydrochloride 25 mg Tablets If you:

•    have liver or kidney problems;

•    have Parkinson’s disease;

•    have epilepsy;

•    have or have ever suffered from depression.

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If any of these apply to you, or If you are not sure, tell your doctor before taking Indoramin Hydrochloride 25 mg 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 other medicines to treat high blood pressure, especially beta-blockers (e.g. propranolol, pindolol) or calcium channel blockers (e.g. diltiazem, nifedipine, verapamil);

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

•    moxisylate for the treatment of Raynauds Syndrome.

Pregnancy and breast-feeding

If you are pregnant, thinking of becoming pregnant oryou are breast-feeding, please talk to your doctor before taking Indoramin Hydrochloride 25 mg Tablets.

Taking Indoramin Hydrochloride 25 mg Tablets with Food and Drink

Do not drink alcohol while taking Indoramin Hydrochloride 25 mg 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 Indoramin Hydrochloride 25 mg 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 Indoramin Hydrochloride 25 mg Tablets

Indoramin Hydrochloride 25 mg Tablets contain lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

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3.    HOW TO TAKE INDORAMIN HYDROCHLORIDE 25 MG TABLETS

Always take Indoramin Hydrochloride 25 mg 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 reguire as much as other patients and may be given a smaller dose or less freguent dosing.

If you take more Indoramin Hydrochloride 25 mg Tablets than you should

If you take more Indoramin Hydrochloride 25 mg Tablets than you should, contactyour doctor or nearest hospital emergency department immediately. Take the container and any remaining tablets with you.

If you forget to take Indoramin Hydrochloride 25 mg Tablets

If you forget to take a dose, just take the next dose at the usual time. DO NOT take a double dose.

4.    POSSIBLE SIDE EFFECTS

Like all medicines Indoramin Hydrochloride 25 mg 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 Indoramin Hydrochloride 25 mg Tablets may include:

•    palpitations;

•    diarrhoea;

•    dry mouth, headache, nasal congestion;

•    feeling sick, dizziness;

•    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.    HOWTO STORE INDORAMIN HYDROCHLORIDE 25 MG 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 Indoramin Hydrochloride 25 mg 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 Indoramin Hydrochloride 25 mg Tablets look like and contents of the pack

Indoramin Hydrochloride 25 mg Tablets are round, blue tablets with ‘MPL 020’ imprinted on one side and ‘25’ on the other face. Indoramin Hydrochloride 25 mg 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,

Regency House,

Miles Gray Road,

Basildon,

Essex SS14 3AF.

Distributed by:

Waymade PLC, trading as Sovereign Medical, Sovereign House,

Miles Gray Road,

Basildon,

Essex,

SS14 3FR.

Date of preparation: May 2009

8094356000

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