MINIPRES 5 mg TABLETS

2. What you need to know before taking Minipres

Do not takeMinipres:

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

Warnings and precautions

Consult 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 the operation, which can be taken into account and controlled by your ophthalmologist if they have been previously informed.
• 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.

Use ofMinipreswith other medicines

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

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 pills: 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.

TakingMinipreswith food and drinks

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 plan to become pregnant, consult your doctor or pharmacist before using 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 your doctor's instructions for taking this medicine exactly. If you are unsure, consult your doctor or pharmacist again.

Adults

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

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

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

Elderly and patients with liver impairment

Your doctor will monitor the dose adjustment.

If you take moreMinipresthan you should

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

Bring 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 takeMinipres

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 takingMinipres

Do not stop taking Minipres unless your doctor tells you to. If you have any further questions about 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 everyone 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
• fatigued breathing, 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 skin sensitivity 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 men, prolonged and painful erections
• fever, pain
• false positive immune system tests
• priapism (prolonged and painful erections)

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

Reporting side effects:

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: 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 sight and reach of children.

Do not store above 30°C.

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition ofMinipres

The active ingredient is prazosin.

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

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

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

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

Appearance of the product and package contents

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

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

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

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

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

Marketing authorization 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 updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/