MINIPRES 1 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 medication (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 medications

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

There are some medications that may interact with Minipres:

• Heart medications: digitalis, digoxin, procainamide, propranolol, and quinidine
• Medications to regulate 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 coagulation (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 medication.

Driving and using machines

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

Minipres contains sodium

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

3. How to take Minipres

Follow the administration instructions for this medication exactly as indicated by your doctor. If in doubt, 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 medication 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 hepatic 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 medication and the amount used.

Bring the remaining tablets, the box, and the complete packaging so that hospital staff can easily identify the medication 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 medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience 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 males, prolonged and painful erections
• fever, pain
• false positive immune system tests
• priapism (prolonged and painful erections)

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

Reporting side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Minipres

Keep out of sight and reach of children.

Do not store above 30°C.

Do not use this medication after the expiration date shown on the packaging and outer carton, after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition ofMinipres

The active ingredient is prazosin.

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

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

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

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

Appearance of the product and package contents

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

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

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

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

The Minipres 5 mg tablets are available in blister packs 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 medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/