MINIPRES 2 mg TABLETS

Introduction

Package Leaflet: Information for the User

MINIPRES 1mg Tablets

MINIPRES 2mg Tablets

MINIPRES 5mg Tablets

Prazosin Hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Minipres and what is it used for
2. What you need to know before taking Minipres
3. How to take Minipres
4. Possible side effects
5. Storage of Minipres
6. Contents of the pack and further information

1. What is Minipres and what is it used for

Minipres is indicated for the treatment of high blood pressure in the arteries (arterial hypertension), Raynaud's disease (narrowing of the capillaries in the hands and feet), and for the treatment of symptoms associated with urinary flow obstruction in benign prostatic hyperplasia (BPH).

2. What you need to know before taking Minipres

Do not takeMinipresif:

• you are allergic to the active substance (prazosin) or to other quinazolines (e.g., doxazosin, terazosin) or to any of the other ingredients of this medicine (listed in section 6).

Warnings and Precautions

Talk to your doctor or pharmacist before starting to take Minipres.

• As with other antihypertensive medications, the administration of Minipres may cause postural hypotension characterized by dizziness, weakness, or rarely loss of consciousness (syncope). Your doctor will inform you about how to avoid symptoms resulting from hypotension and what measures to take if these symptoms occur.
• If you are elderly or being treated for Raynaud's disease, your doctor will monitor your blood pressure during the start of treatment.
• If you are going to undergo cataract surgery, please inform your doctor before the operation if you are taking or have previously taken Minipres. This is because Minipres may cause complications during surgery, which can be taken into account and controlled by your ophthalmologist if informed beforehand.
• If you experience prolonged and sometimes painful erections. This usually occurs rarely. If you have erections that last more than 4 hours, contact your doctor immediately.

Children and Adolescents

The safety and efficacy of Minipres in the treatment of patients under 18 years of age have not been established.

Minipres is not recommended for use in patients under 18 years of age.

Using Minipres with other Medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

There are some medicines that may interact with Minipres:

• Heart medications: digitalis, digoxin, procainamide, propranolol, and quinidine
• Medications to regulate your blood sugar levels: insulin, chlorpropamide, phenformin, tolazamide, and tolbutamide
• Sedatives and sleeping medications: chlordiazepoxide, diazepam, and phenobarbital
• Medications for gout: allopurinol, colchicine, and probenecid
• Medications for pain, fever, and inflammation: propoxyphene, aspirin, indomethacin, and phenylbutazone
• Medications to reduce blood clotting (coumarin type)
• Certain medications to reduce blood pressure (thiazide diuretics)
• Medications for erectile dysfunction

Minipres may affect the results of diagnostic tests for pheochromocytoma.

Taking Minipres with Food and Drink

Minipres can be taken at any time of day, preferably with food.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and Using Machines

Do not drive or operate machinery if you feel dizzy after taking this medicine.

Minipres contains Sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

3. How to Take Minipres

Follow exactly the administration instructions of this medicine indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Adults

The usual initial dose of Minipres is one 1mg tablet per day, divided into two daily doses. If necessary, your doctor may gradually increase the dose at 4-day intervals, up to a maintenance dose of up to 20mg in the treatment of arterial hypertension. The maintenance dose in the treatment of Raynaud's disease is 4-6mg and in benign prostatic hyperplasia is 4mg. It is recommended that on the first day of treatment, the medication be administered with dinner.

Minipres should be swallowed whole, with the help of a little water. The tablets can be taken orally at any time of day, preferably with food.

If you think the action of the Minipres tablets is too strong or too weak, tell your doctor or pharmacist.

Elderly and Patients with Hepatic Impairment

Your doctor will monitor the dose adjustment.

If you take more Minipres than you should

If for any reason you have taken more Minipres than you should, talk to your doctor or pharmacist immediately or call the Toxicology Information Service. Telephone 91 562 04 20, indicating the medicine and the amount used.

Take the remaining tablets, the box, and the complete packaging so that hospital staff can easily identify the medicine you have taken.

If you forget to take Minipres

If you forget to take a dose, take the next scheduled dose at the correct time.

Do not take a double dose to make up for forgotten doses.

If you stop taking Minipres

Do not stop taking Minipres unless your doctor tells you to. 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.

Common side effects (affect less than 1 in 10 people):

• depression, nervousness
• dizziness, drowsiness, headache, temporary loss of consciousness, loss of consciousness
• blurred vision
• vertigo
• palpitations
• breathlessness, nasal congestion
• constipation, diarrhea, nausea, vomiting, dry mouth
• rash
• increased urination
• fluid retention, fatigue, weakness, lack of energy

Uncommon side effects (affect less than 1 in 100 people):

• difficulty sleeping (insomnia)
• decreased sensitivity in the skin to touch or pain, numbness or tingling in the fingers and toes
• eye pain, eye redness
• ringing in the ears
• chest pain, faster than normal heart rate
• nosebleeds
• abdominal discomfort
• excessive sweating, itching, rash
• joint pain
• impotence
• malaise

Rare side effects (affect less than 1 in 1,000 people):

• allergic reaction
• hallucinations
• worsening of daytime sleepiness
• slower than normal heart rate, redness, hypotension, postural hypotension, inflammation of the veins or arteries
• pancreatitis
• liver function changes, hair loss, chronic skin disease with scaly plaques
• urinary incontinence
• abnormal breast growth in males, prolonged and painful erections
• fever, pain
• false positive immune system tests
• priapism (prolonged and painful erections)

If any of these side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Reporting of side effects:

If you experience 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 through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Minipres

Keep out of the sight and reach of children.

Do not store above 30°C.

Do not use this medicine after the expiry date which is stated on the packaging and outer carton, after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Minipres

The active substance is prazosin.

The other ingredients (excipients) are: microcrystalline cellulose, calcium hydrogen phosphate, maize starch, magnesium stearate and sodium lauryl sulfate.

The 1mg Minipres tablets contain 1mg of prazosin as prazosin hydrochloride.

The 2mg Minipres tablets contain 2mg of prazosin as prazosin hydrochloride.

The 5mg Minipres tablets contain 5mg of prazosin as prazosin hydrochloride.

Appearance of the Product and Contents of the Pack

The 1mg Minipres tablets are white, oblong, with a score line on one face and engraved with "M6" on the same face.

The 2mg Minipres tablets are white, round, with a score line on one face and engraved with "M7" on the opposite face.

The 5mg Minipres tablets are white, rhomboid, with a score line on one face and engraved with "M8" on the opposite face.

The 1mg and 2mg Minipres tablets are available in packs with blisters containing 60 tablets.

The 5mg Minipres tablets are available in packs with blisters containing 30 tablets.

Marketing Authorisation Holder

Pfizer, S.L.

Avda. de Europa, 20B – Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Manufacturer

FARMASIERRA MANUFACTURING, S.L.

Ctra. N-I, Km 26,200

28709 San Sebastián de los Reyes (Madrid).

Date of the last revision of this leaflet: October 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/