NORMOTHEN 2 mg Coated Tablet

Содержание инструкции

1. NORMOTHEN 2 mg tablets, 4 mg tablets
   1. What is Normothen and what is it used for
   2. What you need to know before you take Normothen
   3. How to take Normothen
   4. Possible side effects
   5. How to store Normothen
   6. Contents of the pack and other information

NORMOTHEN 2 mg tablets, 4 mg tablets

Doxazosina

Read this leaflet carefully before you start taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Normothen is and what it is used for
• 2. What you need to know before you take Normothen
• 3. How to take Normothen
• 4. Possible side effects
• 5. How to store Normothen
• 6. Contents of the pack and other information

1. What is Normothen and what is it used for

Normothen contains the active substance doxazosin, which belongs to a group of medicines called
alpha-blockers. It is used for the treatment of high blood pressure (essential hypertension).
Normothen works by relaxing the blood vessels, allowing blood to pass more easily through them.
This helps to lower blood pressure.

2. What you need to know before you take Normothen

Do not take Normothen

• If you are allergic to doxazosin, to other types of quinazolines (such as prazosin or terazosin) or to any of the other ingredients of this medicine (listed in section 6).
• If you have an enlarged prostate gland (benign prostatic hyperplasia) together with difficulty urinating, chronic urinary tract infection, or bladder stones.
• If you have suffered from a condition known as "orthostatic hypotension", a form of low blood pressure that causes dizziness or a feeling of lightheadedness when getting up from a sitting or lying position.
• If you suffer from a particular form of urinary incontinence in which there is involuntary loss of urine that occurs as a result of an overfull bladder, or if you do not produce an adequate amount of urine, with or without a progressive loss of kidney function.

Warnings and precautions
Talk to your doctor or pharmacist before taking Normothen.
When you start taking Normothen you may feel a sense of weakness, dizziness and, rarely, fainting
caused by a drop in blood pressure when getting up from a sitting or lying position. If you
experience a feeling of weakness, dizziness, or fainting, you should sit or lie down until you
feel better and avoid situations where you could fall or get injured. Your doctor may decide to
measure your blood pressure regularly at the beginning of treatment to reduce the possibility that
these side effects occur.
If you are about to undergo eye surgery for cataracts (clouding of the lens),
tell your ophthalmologist before the operation that you are using or have previously used
Normothen. Normothen may cause complications during surgery that can be
managed if the specialist is warned in advance.
Tell your doctor or pharmacist before taking Normothen if any of the following conditions apply to you,
because in these cases Normothen must be used with caution:

• If you suffer from a heart condition.
• If you suffer from or have suffered from a liver disease.
• If you are taking medicines for the treatment of erectile dysfunction (impotence), called phosphodiesterase 5 inhibitors (e.g. sildenafil, tadalafil and vardenafil), as both medicines have the effect of lowering blood pressure by dilating blood vessels. The simultaneous use of Normothen and these other medicines could cause an excessive drop in blood pressure (see Other medicines and Normothen). To reduce the likelihood of symptoms occurring, you will need to start Normothen therapy first, taking a regular daily dose. Then, when the Normothen therapy is stabilized, you can start taking medicines for erectile dysfunction.

Persistent painful erections of the penis –can occur very rarely. If this happens, contact
your doctor immediately.

Children and adolescents
Normothen is not recommended for use in children and adolescents under 18 years of age as the
safety and efficacy of treatment have not been established.

Other medicines and Normothen
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines.
Tell your doctor or pharmacist before use if you are taking any of the following medicines,
as they may affect the effect of Normothen:

• Medicines called phosphodiesterase type 5 inhibitors for the treatment of erectile dysfunction, such as sildenafil, tadalafil and vardenafil (see Warnings and precautions).
• Medicines that lower blood pressure.
• Medicines for the treatment of bacterial or fungal infections, such as clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole.
• Medicines used to treat HIV, such as indinavir, nelfinavir, ritonavir, saquinavir.
• Nefazodone, a medicine used to treat depression.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The safety of using Normothen during pregnancy has not been established. Therefore, if you are
pregnant, your doctor will prescribe Normothen only if the potential benefits outweigh the risks.
Breastfeeding
Small amounts of doxazosin may be found in breast milk. Do not breastfeed your baby unless
your doctor advises you to do so.

Driving and using machines
Be careful if you drive or use machines. These tablets may impair your ability
to drive or operate machinery safely, especially at the beginning of treatment. They may
cause you to feel weak or dizzy. If you experience these symptoms, do not drive or operate machinery
and contact your doctor immediately.

Normothen contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact him/her before taking this
medicine.

Normothen contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Normothen

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The initial dose of Normothen is 1 mg administered as a single dose every day.
After one or two weeks, your doctor may increase the dose to 2 mg per day. If necessary, after a
further period of one or two weeks, your doctor may decide to increase the dose again to 4 mg per
day. The doctor, after a further period of one or two weeks and if necessary, may increase
the dose again to 8 mg per day, until lowering blood pressure to the desired level. In some cases
the dose may be increased up to a maximum of 16 mg per day.
The usual dose is 2 – 4 mg per day. The maximum recommended dose is 16 mg per day. If necessary,
your doctor will tell you to take other medicines together with Normothen to achieve the desired effect.
Normothen can be taken indifferently in the morning or evening.

If you take more Normothen than you should
Taking too many tablets together can make you feel unwell as your blood pressure drops
excessively. If this happens, lie down. Taking many tablets can
be dangerous. If you take more Normothen than you should, inform your doctor immediately or go to the
emergency room of the nearest hospital.

If you forget to take Normothen
If you forget to take Normothen, skip the dose completely. Do not take a double dose to
make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of these symptoms, STOP taking Normothen and call an
ambulance immediately:

• chest pain, chest discomfort (angina, myocardial infarction);
• feeling of difficulty breathing (dyspnea), accompanied by discomfort and tightness in the chest (bronchospasm);
• sudden headache, feeling of fainting, weakness in the arms, legs, or problems with speech, which may be symptoms of a stroke;
• swelling of the face and allergic reactions.

Immediatelyinform your doctor if, after taking Normothen, you experience any of the following symptoms:

• fast, slow, or irregular heartbeat;
• awareness of your heartbeat (palpitations);
• yellowing of the skin or eyes (jaundice);
• low number of white blood cells or platelets in the blood. These situations can respectively lead to an increased susceptibility to infections or increased bruising or a tendency to bleed.

The following adverse events have also been reported in patients treated with Normothen.

Common side effects(may affect up to 1 in 10 people)

• feeling of dizziness or spinning around (vertigo), headache;
• low blood pressure or a drop in pressure when going from a sitting or lying position to a standing position;
• swelling of feet, ankles, or toes;
• bronchitis, cough, respiratory tract infection (nose, throat, lungs);
• stuffy nose, sneezing, and/or runny nose due to inflammation of the nasal mucosa (rhinitis);
• abdominal pain, nausea;
• urinary tract infection, urinary incontinence (inability to control and retain urine), bladder inflammation (cystitis);
• drowsiness, general weakness;
• feeling of fullness and discomfort in the stomach, dry mouth;
• itching;
• chest pain, back pain, muscle pain;
• flu-like symptoms.

Uncommon side effects(may affect up to 1 in 100 people)

• constipation, flatulence, inflammation of the stomach and intestines (gastroenteritis) which can cause diarrhea and vomiting;
• pain or discomfort when urinating, needing to urinate more often than usual, blood in the urine;
• swelling of the joints (gout), joint pain, generalized pain;
• swelling of the face;
• insomnia, agitation, anxiety, depression, or nervousness;
• temporary loss of consciousness;
• reduced or altered sensitivity to touch in hands and feet;
• increased or decreased appetite, weight gain;
• nosebleeds;
• skin rash;
• ringing or buzzing in the ears, tremor;
• inability/incapacity to achieve or maintain an erection of the penis;
• increased liver enzymes which can alter some medical tests.

Rare side effects(may affect up to 1 in 1,000 people)

• increased number of times you need to urinate;
• muscle cramps, muscle weakness.

Very rare side effects(may affect up to 1 in 10,000 people)

• hepatitis (inflammation of the liver) or biliary disorder (cholestasis);
• hives, hair loss, red or purple spots on the skin due to bleeding under the skin or mucous membranes (purpura);
• feeling of tingling or numbness in hands and feet;
• fatigue, general feeling of unwellness;
• blurred vision;
• hot flashes;
• urinary disorders, needing to urinate at night, increased urine volume;
• enlargement of the breasts in men;
• painful persistent erection of the penis. Seek immediate medical attention;
• sudden dizziness accompanied by loss of balance.

Other side effects(frequency cannot be estimated based on available data)

• retrograde ejaculation (semen is ejaculated not externally but into the bladder), which can cause cloudy urine after orgasm;
• problems with the eyes may occur during surgery for cataracts (clouding of the lens). See section "Warnings and precautions".

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Normothen

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 pack after “Expiry”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Normothen contains
The active ingredient is doxazosin.
Each 2 mg tablet contains 2.43 mg of doxazosin mesylate equivalent to 2 mg of doxazosin.
Each 4 mg tablet contains 4.85 mg of doxazosin mesylate equivalent to 4 mg of doxazosin.
The other ingredients are: microcrystalline cellulose, lactose, sodium starch glycolate, magnesium stearate,

sodiumlauryl sulfate.

Description of Normothen and contents of the pack
Blisters in PVC-PVDC/opaque aluminum with titanium dioxide.
Pack containing 30 divisible 2 mg tablets in blisters.
Pack containing 20 divisible 4 mg tablets in blisters.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pfizer Established Medicine Italy S.r.l., Via Isonzo, 71 – 04100 Latina

Manufacturer
R-Pharm Germany GmbH
Heinrich-Mack-Str. 35, 89257 Illertissen
Germany
Pfizer Manufacturing Deutschland GmbH
Freiburg Site Mooswaldallee 1
79090 Freiburg
Germany