Prospect: information for the user

MINIPRES 1mg tablets

MINIPRES 2 mg tablets

MINIPRES 5 mg tablets

Prazosin hydrochloride

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.

1.What Minipres is and for what it is used

2.What you need to know before taking Minipres

3.How to take Minipres

4.Possible adverse effects

5.Storage of Minipres

6.Contents of the package and additional information

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

Do not takeMinipres:

• if you are allergic to the active ingredient (prazosin) or to other quinazolines (such as 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 takeMinipres.

• As with other anti-hypertensive medications, the administration ofMinipresmay cause postural hypotension characterized by dizziness, weakness, or rarely by loss of consciousness (syncope). Your doctor will inform you about how to avoid the symptoms resulting from hypotension and what measures to take if those 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 to undergo eye surgery for cataracts, please inform your doctor before the surgery if you are taking or have takenMiniprespreviously. This is becauseMinipresmay cause complications during the surgery, which can be taken into account and controlled by your ophthalmologist if you have been informed previously.
• 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 have not been established.

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

Use ofMinipreswith other medications

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

There are some medications that may interact withMinipres:

• Heart medications: digitalis, digoxin, procainamide, propranolol, and quinidine
• Blood sugar level medications: insulin, chlorpropamide, fenformin, tolazamide, and tolbutamide
• Sedatives and sleep medications: clordiazepoxide, diazepam, and phenobarbital
• Gout medications: allopurinol, colchicine, and probenecid
• Pain, fever, and inflammation medications: propoxyphene, aspirin, indomethacin, and phenylbutazone
• Blood thinners (type coumarin)
• Certain blood pressure medications (thiazide diuretics)
• Erectile dysfunction medications

Minipresmay affect the results of diagnostic tests for phaeochromocytoma.

TakingMinipreswith food and drinks

Miniprescan be takenat any time of the 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 operating machinery

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”.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Adults

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

Minipresshould be swallowed whole with a little water. Tablets can be taken orallyat any time of the day, preferably with food.

If you estimate that the effect ofMiniprestablets is too strong or too weak, inform your doctor or pharmacist.

Older adults and patients with liver insufficiency

Your doctor will monitor the dose adjustment.

If you take moreMinipresthan you should

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

Bring the remaining tablets, the packaging, and the complete box 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 compensate for the missed doses.

If you interrupt treatment withMinipres

Do not stop takingMinipresunless your doctor tells you to. If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Frequent 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
• skin rash
• increased frequency of urination
• fluid retention, fatigue, weakness, lack of energy

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

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

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

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

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 System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

Do not store at a temperature above 86°F (30°C).

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

Medicines should not be disposed of through drains or in the trash. Dispose of containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition ofMinipres

The active ingredient is prazosin.

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

The 1 mg tablets ofMiniprescontain 1 mg of prazosin as prazosin hydrochloride.

The 2 mg tablets ofMiniprescontain 2 mg of prazosin as prazosin hydrochloride.

The 5 mg tablets ofMiniprescontain 5 mg of prazosin as prazosin hydrochloride.

Appearance of the product and contents of the packaging

The 1 mg tablets ofMinipresare white, oblong, with a notch on one face and engraved with “M6” on the same face.

The 2 mg tablets ofMinipresare white, round, with a notch on one face and engraved with “M7” on the opposite face.

The 5 mg tablets ofMinipresare white, rhomboidal, with a notch on one face and engraved with “M8” on the opposite face.

The 1 mg and 2 mg tablets ofMinipresare available in boxes with blisters containing 60 tablets.

The 5 mg tablets ofMinipresare available in boxes with blisters containing 30 tablets.

Marketing authorization holder

Pfizer, S.L.

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

28108 Alcobendas (Madrid)

Responsible manufacturer

FARMASIERRA MANUFACTURING, S.L.

Ctra. N-I, Km 26,200

28709 San Sebastián de los Reyes (Madrid).

Last review date of this leaflet: October 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices(AEMPS)http://www.aemps.gob.es/