1 mg, 2 mg, 5 mg, 10 mg tablet
Terazosin
What Sinalfa is and what it is used for
Sinalfa belongs to a group of medicines called alpha-receptor blockers that are used to treat diseases such as high blood pressure and certain prostate diseases.
Sinalfa reduces blood pressure by dilating the small peripheral blood vessels (located far from the heart). This reduces the resistance to heart work. Sinalfa does not act directly on the vessel wall but via the nerves that affect the vessel.
With the benign enlargement of the prostate, Sinalfa relaxes the muscles in the gland ( prostate ) that encloses the innermost part of the man’s urethra. This means that it becomes easier to urinate and that the discomfort is reduced.
Sinalfa relieves the problems of benign prostate enlargement. It can also be used for high blood pressure and is often combined with other blood pressure lowering agents.
Terazosin contained in Sinalfa may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Sinalfa
Do not take Sinalfa
- if you are allergic to terazosin or any of the other ingredients of this medicine (listed in section 6).
- if you are allergic to other alpha-receptor blockers (drugs used to treat diseases such as high blood pressure and to treat prostate diseases)
- if you have previously had a drop in blood pressure when you got up and urinated.
- Sinalfa is not recommended for children.
Warnings and cautions
Talk to your doctor or pharmacist before taking Sinalfa.
- if you have impaired liver function
When you take Sinalfa for the first time, when you increase the dose once or after a break, and resume treatment after a period without the medicine, you may have a drop in blood pressure when you quickly sit down or stand up. This can cause dizziness and the risk of fainting. The risk of low blood pressure is higher with the concomitant use of certain other medicines. See section “Other medicines and Sinalfa”.
If you are going to undergo eye surgery due to cataracts (turbidity of the eye’s lens, you should inform your eye specialist before the operation that you are using or have used Sinalfa.
This is because the use of Sinalfa can cause complications during the surgery which can be managed if your specialist is informed.
Other medicines and Sinalfa
Tell your doctor or pharmacist if you have recently taken, or might take any other medicines.
You must tell your doctor if you are taking Sinalfa with:
- other medicines for high blood pressure such as so-called beta- blockers, ACE inhibitors, diuretics, calcium channel blockers, or clonidine. The antihypertensive effect may be enhanced by concomitant treatment and may cause symptoms such as dizziness or fainting, especially at the beginning of treatment.
- certain drugs for impotence e.g. sildenafil, tadalafil, vardenafil. The antihypertensive effect can be enhanced with concomitant treatment and cause symptoms such as dizziness or fainting.
Pregnancy and breastfeeding
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.
Pregnancy:
Experience with use during pregnancy is limited. Sinalfa should therefore be used during pregnancy only after special consideration in consultation with a doctor.
Breast-feeding:
It is unknown if Sinalfa passes into breast milk.
Driving and using machines
Sinalfa has a significant effect on the ability to drive and use machines.
The reactivity may be impaired in some patients treated with Sinalfa at the beginning of treatment, but also when changing dose one.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Sinalfa contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take Sinalfa
Always take this medicine exactly as your doctor has told you. Consult a doctor if you are unsure. Dose one is determined by the doctor, who adjusts it individually for you.
The usual dose for benign prostatic hyperplasia: Sinalfa is taken once a day. You start with 1 tablet of 1 mg at bedtime during the first week, then 1 tablet of 2 mg at bedtime during the second week. For practical reasons, the first 14 tablets (7 to 1 mg and 7 to 2 mg) are available in one package. Be aware that during the first week you are taking the weaker tablets (1 mg). During the third week, increase the dose by one to 1 tablet of 5 mg at bedtime. From the fourth week, take a dose of 5-10 mg at bedtime according to your doctor’s prescription.
The usual dose for high blood pressure: Sinalfa is dosed once a day. You start with 1 tablet of 1 mg at bedtime for 4 days, then take 1 tablet of 1 mg in the morning for 3 days. In the second week, you take 1 tablet of 2 mg in the morning. If you do not get a sufficient reduction in your blood pressure, increase the dose from one to 1 tablet of 5 mg during the third week. A further dose increase may be necessary.
Do not stop treatment with Sinalfa, and do not change the dosage on your own without first consulting your doctor.
If you take more Sinalfa than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you forget to take Sinalfa
Do not take a double dose to make up for a forgotten tablet.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Sinalfa and contact a doctor immediately if you experience any of the following symptoms:
- shortness of breath, shortness of breath.
- swelling of the face, tongue, or throat; difficulty swallowing; hives, and difficulty breathing. This may be a symptom of angioedema reported in an unknown number of Sinalfa users.
The most common side effect (in about 10-15 patients in 100) is dizziness at the beginning of treatment and when the dose is increased. Most often, dizziness occurs when getting up.
Common (may affect up to 1 in 10 people):
- Drowsiness
- Impotence
- Dimsyn
- Drop in blood pressure when getting up
- Palpitation
- Swelling
- Nasal congestion
- Nausea
- Impotence
- Headache
- Dizziness
Uncommon (may affect up to 1 in 100 people):
- Fainting.
Rare (may affect up to 1 in 1,000 people):
- Reduction in the number of platelets ( platelets ) in the blood
- Heart fibrillation
- Urinary incontinence
- Painful and prolonged erection of the penis.
Has been reported (occurs in an unknown number of users)
- Skin hypersensitivity reactions
- Depression
- Dizziness
- Impaired vision
- Palpitations (heart beating too fast)
- Itching, rash, and redness of the skin
- Urinary tract infection
- Decreased sexual desire
- Swelling due to accumulation of fluid
How to store Sinalfa
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
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 to protect the environment.
Contents of the pack and other information
What Sinalfa contains
- The active substance is terazosin hydrochloride equivalent to terazosin 1 mg, 2 mg, 5 mg, or 10 mg per tablet
- The other ingredients are lactose, maize starch, pregelatinized starch, talc, magnesium stearate, quinoline yellow E104 (tab. 2 mg), iron oxide E172 (tab. 5 mg), indigo carmine E132 (tab. 10 mg).
What the medicine looks like and the contents of the pack
Printing packaging.
Starter pack: 1 mg x 7 + 2 mg x 7
2 mg x 28 and 2 mg x 98 pcs
5 mg x 28 and 5 mg x 98 pcs
Marketing Authorization Holder and Manufacturer
Amdipharm Limited
Temple Chambers
3 Burlington Road
Dublin 4
Ireland
Tel. +44 1268 82 3049
Manufacturer:
Aesica Queenborough Limited
Queenborough, Kent
ME11 5EL
England
or
Aesica Pharmaceuticals SRL
Via Praglia, 15
10044 Pianezza
Italy
or
Famar Italia SPA
Via Zambeletti, 25 – 20021
Baranzate, Milano,
Italy