Package leaflet: Information for the patient

NORMOTHEN 2 mg tablets, 4 mg tablets

Doxazosin
Please read all of this leaflet carefully before taking this medicine because 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Normothen is and what it is used for
What you need to know before taking Normothen
How to take Normothen
Possible side effects
How to store Normothen
Contents of the pack and other information

1. What Normothen is and what it is used for

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

2. What you need to know before taking 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 causing dizziness or a feeling of faintness upon standing up from a sitting or lying position.
If you have a particular type of urinary incontinence in which involuntary urine leakage occurs as a result of an overfilled 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 experience weakness, dizziness, and, rarely, fainting due to a drop in blood pressure upon standing up from a sitting or lying position. If you feel weak, dizzy, or faint, sit or lie down until you feel better and avoid situations where you might fall or get injured. Your doctor may decide to monitor your blood pressure regularly at the beginning of treatment to reduce the likelihood of these side effects.
If you are about to undergo eye surgery for cataract (a clouding of the lens), inform your ophthalmologist before the operation that you are currently taking or have previously taken Normothen. Normothen may cause complications during eye surgery, which can be managed if the specialist is informed in advance.
Inform your doctor or pharmacist before taking Normothen if any of the following apply to you, as Normothen should be used with caution in these cases:

If you have a heart condition.
If you have or have had a liver disease.
If you are taking medicines for erectile dysfunction (impotence), called phosphodiesterase 5 inhibitors (e.g., sildenafil, tadalafil, and vardenafil), as both medicines lower blood pressure by dilating blood vessels. Taking Normothen together with these medicines may cause excessive lowering of blood pressure (see Other medicines and Normothen). To reduce the likelihood of symptoms, you should first start treatment with Normothen by taking a daily dose regularly. Then, once your treatment with Normothen is stabilized, you may begin taking medicines for erectile dysfunction.

Prolonged painful erections of the penis – may occur very rarely. If this happens, contact a 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 the treatment have not been established.
Other medicines and Normothen
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor or pharmacist before use if you are taking any of the following medicines, as they may affect the action 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 used to treat 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, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The safety of using Normothen during pregnancy has not been established. Therefore, your doctor will prescribe Normothen only if the potential benefits outweigh the risks.
Breastfeeding
Small amounts of doxazosin may pass into breast milk. Do not breastfeed unless your doctor advises you to do so.
Driving and using machines
Exercise caution if driving or operating machinery. These tablets may impair your ability to drive or operate machinery safely, especially at the beginning of treatment. They may cause weakness or dizziness. If you experience these symptoms, do not drive or operate machinery and contact your doctor immediately.
Normothen contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult your doctor 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 exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The initial dose of Normothen is 1 mg taken as a single dose every day.
After one or two weeks, your doctor may increase the dose to 2 mg daily. If necessary, after a further period of one or two weeks, your doctor may decide to increase the dose again to 4 mg daily. After another period of one or two weeks, and if needed, your doctor may further increase the dose to 8 mg daily, until the desired blood pressure level is achieved. In some cases, the dose may be increased up to a maximum of 16 mg daily.
The usual dose is 2 – 4 mg daily. The maximum recommended dose is 16 mg daily. If necessary, your doctor may instruct you to take other medicines together with Normothen to achieve the desired effect.
Normothen may be taken either in the morning or in the evening.
If you take more Normothen than you should
Taking too many tablets at once may make you feel unwell due to excessive lowering of blood pressure. If this happens, lie down in a supine position. Taking a large number of tablets may be dangerous. If you take more Normothen than you should, contact your doctor immediately or go to the nearest hospital emergency department.
If you forget to take Normothen
If you forget to take Normothen, skip the missed dose completely. Do not take a double dose to make up for the forgotten dose.

4. Possible side effects

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

chest pain, pain in the chest (angina, myocardial infarction);
shortness of breath (dyspnea), accompanied by discomfort and tightness in the chest (bronchospasm);
sudden headache, feeling faint, weakness in the arms or legs, or difficulty speaking, which could be symptoms of a stroke;
swelling of the face and allergic reactions.

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

fast, slow or irregular heartbeat;
awareness of your own heartbeat (palpitations);
yellowing of the skin or eyes (jaundice);
low white blood cell or platelet count in the blood. These conditions may lead to an increased susceptibility to infections or increased bruising or tendency to bleed, respectively.

The following adverse events have also been reported in patients treated with Normothen.
Common side effects (may affect up to 1 in 10 people)

dizziness, spinning sensation (vertigo), headache;
low blood pressure, or drop in blood pressure when moving from a sitting or lying position to standing;
swelling of feet, ankles or fingers;
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 or retain urine), bladder inflammation (cystitis);
drowsiness, generalized 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 intestine (gastroenteritis) which may cause diarrhoea and vomiting;
pain or discomfort when urinating, need to urinate more frequently than usual, blood in the urine;
joint swelling (gout), joint pain, generalized pain;
facial swelling;
insomnia, restlessness, 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 (tinnitus), tremor;
inability/inability to achieve or maintain penile erection;
increased liver enzymes, which may alter certain medical tests.

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

increased frequency of needing to urinate;
muscle cramps, muscle weakness.

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

hepatitis (liver inflammation) or bile disorder (cholestasis);
urticaria, hair loss, red or purple spots on the skin due to bleeding under the skin or mucous membranes (purpura);
tingling or numbness in hands and feet;
fatigue, general feeling of malaise;
blurred vision;
hot flushes;
urinary disturbances, need to urinate at night, increased urine volume;
breast enlargement in men;
prolonged painful penile erection. Seek immediate medical attention;
sudden dizziness accompanied by loss of balance.

Other side effects (frequency cannot be determined from available data)

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 packaging after “Expiry”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Normothen contains
The active substance 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 glycolate starch, magnesium stearate, sodium lauryl sulfate.
Description of the appearance of Normothen and the contents of the pack
PVC-PVDC/Aluminum blisters, opacified with titanium dioxide.
Carton pack containing 30 divisible 2 mg tablets in blisters.
Carton pack containing 20 divisible 4 mg tablets in blisters.
Marketing Authorization Holder and Manufacturer
Marketing Authorization 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
Betriebsstätte Freiburg Mooswaldallee 1
79090 Freiburg
Germany