Natrilix: detailed information

PACKAGE LEAFLET

Package leaflet: information for the patient

NATRILIX 2.5 mg film-coated tablets

Indapamide
Please read 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, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Natrilix is and what it is used for
What you need to know before taking Natrilix
How to take Natrilix
Possible adverse effects
How to store Natrilix
Package contents and other information

1. What Natrilix is and what it is used for

Natrilix is a medicine containing indapamide, a substance that belongs to a group of medicines called "thiazide diuretics", which increase the amount of urine produced by the kidneys. However, indapamide is different from other diuretics because it causes only a slight increase in the amount of urine produced.
Natrilix is used to reduce high blood pressure (essential arterial hypertension).

2. What you should know before taking Natrilix

Do not take Natrilix:
if you are allergic to indapamide or to any other sulfonamide or to any of the other ingredients of
this medicine ( listed in section 6 );
if you have severe kidney disease (inadequate renal function or absence of urine (anuria));
if you suffer from severe liver problems or a condition called hepatic encephalopathy (brain disturbances due to the circulation of "toxic" substances related to liver failure);
if you have low levels of potassium in your blood (hypokalaemia);
if you have recently had a stroke (cerebral vascular infarction);
if you have phaeochromocytoma (a tumour of the adrenal glands causing increased blood pressure);
if you suffer from a disease called Conn's syndrome (a disorder of the adrenal glands causing excessive production of the hormone aldosterone, leading to increased blood pressure).

Warnings and precautions
Exercise particular caution:
if you have had or currently suffer from low levels of sodium in your blood (hyponatraemia);
if you have had or currently suffer from low levels of potassium in your blood; low potassium levels may occur
in elderly patients, debilitated patients, or those taking multiple medications (polypharmacy), in patients with liver cirrhosis (a liver disease causing fluid accumulation in the abdominal cavity), in patients with heart disease (coronary artery disease or heart failure, long QT syndrome), or in patients suffering from cardiac arrhythmias (particularly torsades de pointes).
if you have been found to have increased levels of calcium in your blood (hypercalcaemia): thiazide diuretics
can reduce calcium excretion in urine and may cause a mild and transient increase in blood calcium levels.
Your doctor may perform blood tests to check whether you have low levels of sodium or potassium or high levels of calcium in your blood.
In addition, you should exercise caution:
if you suffer from gout or diabetes;
if your kidney function is reduced, as Natrilix does not work properly in patients with even slightly impaired kidney function;
if you suffer from liver problems, as Natrilix may trigger the onset of hepatic encephalopathy
(see section Do not take Natrilix );
if you experience visual disturbances or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur within hours or weeks after taking Viacorinda. This may lead to permanent vision loss if not treated.
If you previously had an allergy to penicillin or sulfonamides, you may be at increased risk of developing an allergic reaction;
if you suffer from muscle disorders including muscle pain, tenderness, weakness, or cramps.

Photosensitivity
Cases of photosensitivity reactions (skin reaction to light causing redness and burning sensations; an abnormal and exaggerated reaction even after brief exposure to sunlight) have been reported with the use of indapamide. If such reactions occur, stop treatment and consult your doctor.
If it becomes necessary to resume treatment with indapamide, it is recommended to protect sun-exposed areas or areas exposed to artificial UVA rays.

Children and adolescents
The safety and efficacy of this medicine in children and adolescents under 18 years of age have not been established, and therefore its use is not recommended.

Other medicines and Natrilix
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may alter the effect of Natrilix or may have their effect altered by this medicine, particularly:

lithium (used to treat depression). Natrilix must not be taken with lithium due to the risk of increased lithium levels in the blood;
medicines used for cardiac arrhythmias such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, bretylium;
bepridil (used to treat angina pectoris, a condition causing chest pain);
other diuretics (amiloride, spironolactone, triamterene);
medicines used to treat mental disorders such as depression, anxiety or schizophrenia (e.g. tricyclic antidepressants (e.g. imipramine), antipsychotics, neuroleptics (such as chlorpromazine, carbamazepine, levomepromazine, thioridazine, trifluoperazine, amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol);
antibiotics used to treat bacterial infections (e.g. moxifloxacin, sparfloxacin, intravenous erythromycin);
halofantrine (an antiparasitic drug used to treat gastrointestinal disorders);
pentamidine (a drug acting against certain protozoa);
antihistamines used to treat allergic reactions such as hay fever (e.g. mizolastine, astemizole, terfenadine);
non-steroidal anti-inflammatory drugs (e.g. ibuprofen), including selective COX-2 inhibitors or high doses of salicylic acid;
angiotensin-converting enzyme (ACE) inhibitors used to treat high blood pressure;
antifungal medicines (antimycotics) such as amphotericin B;
baclofen, a medicine used to treat muscle stiffness in conditions such as multiple sclerosis;
metformin, an antidiabetic medicine;
allopurinol, a medicine used in gout;
cyclosporine and tacrolimus, therapies used to prevent organ rejection;
corticosteroids (gluco- and mineralocorticoids), used to treat various conditions including severe asthma and rheumatoid arthritis;
tetracosactide (used as a diagnostic agent or in the treatment of Crohn's disease);
stimulant laxatives, which may cause potassium loss (hypokalaemia);
digitalis glycosides, used in certain heart conditions;
cisapride, difemanil (used to treat gastrointestinal disorders);
calcium tablets or other calcium supplements;
iodine-containing medicines used in radiological investigations (iodinated contrast media);
methadone (used to treat addiction).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
This medicine must not be used during pregnancy.
Use of this medicine is not recommended during breastfeeding, as a risk to newborns/infants cannot be excluded.

Driving and using machines
Natrilix does not affect alertness, but in individual cases different reactions related to blood pressure reduction may occur, especially at the beginning of treatment or when combined with another antihypertensive medicine.

For athletes
Using this medicine without therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.

Natrilix contains lactose:
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

Natrilix contains sodium:
Natrilix contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take Natrilix

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is 1 tablet taken once daily, preferably in the morning, swallowed whole with water without chewing.

Elderly:
Elderly patients may be treated with Natrilix only when renal function is normal or slightly impaired (see section Warnings and precautions). Therefore, before treatment with Natrilix, values of renal function parameters (serum creatinine) must be adjusted according to age, weight, and sex.

Patients with impaired renal function:
If you have kidney problems, consult your doctor, as the usual dose may need to be adjusted. The dose reduction should be based on the degree of renal impairment.
Treatment is contraindicated in case of severe renal impairment (see section Warnings and precautions).

Patients with impaired hepatic function:
If you have liver problems, consult your doctor, as the usual dose may need to be adjusted.
Treatment is contraindicated in case of severe renal impairment (see section Warnings and precautions).

Children and adolescents:
Natrilix is not recommended in children and adolescents due to lack of data on safety and efficacy.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

If you take more Natrilix than you should:
In case of accidental ingestion/overdose of Natrilix, contact your doctor immediately or go to the nearest hospital.
Signs and symptoms of accidental overdose include: nausea, vomiting, excessive drop in blood pressure (hypotension), cramps, dizziness, drowsiness, confusion, frequent need to urinate, followed by reduced urine output or complete absence of urine (oliguria and anuria).

If you forget to take Natrilix:
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.
Common (may affect up to 1 in 10 people):
rash
low blood potassium levels.
Uncommon (may affect up to 1 in 100 people):
vomiting, purpura (small red spots on the skin) in subjects predisposed to allergic reactions, low blood sodium levels which may lead to dehydration and reduced blood pressure, impotence (inability to achieve or maintain an erection).
Rare (may affect up to 1 in 1,000 people):
dizziness, fatigue, headache, drowsiness, tingling sensations (paraesthesia), nausea, constipation, dry mouth, muscle cramps, low blood chloride levels, low blood magnesium levels.
Very rare (may affect up to 1 in 10,000 people):
blood cell disorders (thrombocytopenia, leucopenia, agranulocytosis, aplastic anaemia, haemolytic anaemia);
heart rhythm disorders (arrhythmias);
blood pressure too low (hypotension);
inflammation of the pancreas (pancreatitis);
liver function abnormalities;
angioedema and/or urticaria, severe skin reactions;
severe allergic skin reactions (toxic epidermal necrolysis);
severe allergic reactions (Stevens-Johnson syndrome);
renal failure;
increased calcium levels in the blood (hypercalcaemia).
Frequency not known (frequency cannot be estimated from the available data):
transient loss of consciousness (syncope);
mental confusion;
vision disorders (myopia, blurred vision, visual impairment);
severe heart arrhythmia (torsades de pointes, potentially fatal);
low blood pressure when standing (orthostatic hypotension);
development of a serious liver disease called hepatic encephalopathy (brain disturbances due to circulating "toxic" substances related to liver failure (see section Do not take Natrilix);
inflammatory liver disease (hepatitis);
possible worsening of pre-existing systemic lupus erythematosus (an autoimmune disease causing inflammation and damage to joints, tendons and organs, skin rash, fatigue, loss of appetite, weight gain and joint pain);
rash (transient skin redness);
cases of photosensitivity reactions (see section Warnings and Precautions);
sudden falls;
acute renal failure;
long QT syndrome (a potentially fatal heart rhythm disorder) (see section Warnings and Precautions);
increased levels of sugar (glucose) and uric acid in the blood, and slight increase in blood nitrogen;
elevated liver enzymes;
excessive loss of chlorides in urine (which may lead to mild metabolic alkalosis);
Decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may 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 Natrilix

This medicine does not require any special storage conditions.
Keep the medicine out of the sight and reach of children.
Expiry date: see the expiry date stated on the packaging.
The expiry date refers to the product in its original, undamaged packaging and correctly stored.
Do not use this medicine after the expiry date stated on the carton and on the blister pack. The expiry date refers to the last day of that month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Natrilix contains
The active substance is indapamide. Each film-coated tablet contains 2.5 mg of indapamide.
The other components are:
maize starch, lactose monohydrate, povidone, magnesium stearate, talc.
Film coating: white beeswax, titanium dioxide, glycerol, sodium lauryl sulfate, hypromellose,
macrogol 6000, magnesium stearate.

Description of the appearance of Natrilix and the contents of the pack
Natrilix is supplied in a box containing a blister with 30 film-coated tablets for oral use.

Marketing Authorization Holder
Les Laboratoires Servier
50, rue Carnot
92284 Suresnes cedex
France

Manufacturer
Les Laboratoires Servier Industrie
905, Route de Saran
45520 Gidy - France
or alternatively
SERVIER (Ireland) Industries Ltd.
Gorey Road
Arklow – Ireland

Representative in Italy
Servier Italia S.p.A.
Via Luca Passi, 85
00166 Roma

Package leaflet: Information for the user

Natrilix 1.5 mg prolonged-release tablets

indapamide
Please read 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, consult 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 could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Natrilix 1.5 mg prolonged-release tablets are and what they are used for
What you need to know before taking Natrilix 1.5 mg prolonged-release tablets
How to take Natrilix 1.5 mg prolonged-release tablets
Possible side effects
How to store Natrilix 1.5 mg prolonged-release tablets
Package contents and other information

1. What Natrilix 1.5 mg prolonged-release tablets are and what they are used for

Natrilix 1.5 mg prolonged-release tablets contain indapamide as the active substance.
This medicine is indicated for the reduction of high blood pressure (hypertension) in adults.
Indapamide is a diuretic. Most diuretics increase the amount of urine produced by the kidneys.
However, indapamide differs from other diuretics because it causes only a slight increase in the amount of urine produced.
In addition, indapamide dilates blood vessels, thereby facilitating blood flow. This helps reduce blood pressure.

2. What you need to know before taking Natrilix 1.5 mg prolonged-release tablets

Do not take Natrilix 1.5 mg prolonged-release tablets:

if you are allergic to indapamide or to any other sulfonamide, or to any of the other ingredients of this medicine (listed in section 6),
if you have severe kidney disease,
if you have severe liver disease or suffer from a condition called hepatic encephalopathy (a degenerative brain disorder),
if you have low levels of potassium in your blood.

Warnings and precautions
Talk to your doctor or pharmacist before taking Natrilix 1.5 mg prolonged-release tablets:

if you have liver problems,
if you have diabetes,
if you suffer from gout,
if you have heart rhythm disorders or kidney problems,
if you experience blurred vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure inside the eye, which may occur within hours or weeks after taking Natrilix. This may lead to permanent vision loss if not treated. If you previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing such a reaction,
if you suffer from muscle disorders including muscle pain, tenderness, weakness, or cramps,
if you are scheduled for a test to assess parathyroid gland function. You must inform your doctor if you have ever had photosensitivity reactions. Your doctor may perform blood tests to check whether you have low levels of sodium or potassium, or high levels of calcium in your blood.

If you think you fall into any of the above categories, or have any questions or doubts about how to take this medicine, consult your doctor or pharmacist.
For those engaged in sports: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Other medicines and Natrilix 1.5 mg prolonged-release tablets
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You must not take Natrilix RP 1.5 mg prolonged-release tablets with lithium (used to treat depression) due to the risk of increased lithium levels in the blood.
Make sure to inform your doctor if you are taking any of the following medicines, as special attention may be required:

medicines used for heart rhythm disorders (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitalis, bretylium),
medicines used to treat mental disorders such as depression, anxiety, schizophrenia… (e.g. tricyclic antidepressants, antipsychotics, neuroleptics (such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol)),
bepridil (used to treat angina pectoris, a condition causing chest pain),
cisapride, difemanil (used to treat gastrointestinal disorders),
antibiotics used to treat bacterial infections (e.g. sparfloxacin, moxifloxacin, injectable erythromycin),
injectable vincamine (used in elderly patients for symptomatic treatment of cognitive disorders, including memory loss),
halofantrine (an antiparasitic drug used to treat certain types of malaria),
pentamidine (a medicine used to treat certain types of pneumonia),
antihistamines used to treat allergic reactions, such as hay fever (e.g. mizolastine, astemizole, terfenadine),
non-steroidal anti-inflammatory drugs (NSAIDs) used to treat pain (e.g. ibuprofen) or high-dose acetylsalicylic acid,
angiotensin-converting enzyme (ACE) inhibitors (used to treat hypertension and heart failure),
injectable amphotericin B (an antifungal medicine),
oral corticosteroids used to treat various conditions including severe asthma and rheumatoid arthritis,
stimulant laxatives,
baclofen (to treat muscle stiffness in diseases such as multiple sclerosis),
allopurinol (for the treatment of gout),
potassium-sparing diuretics (e.g. amiloride, spironolactone, triamterene),
metformin (for the treatment of diabetes),
iodinated contrast media (used in X-ray radiological examinations),
calcium tablets or other calcium supplements,
cyclosporine, tacrolimus, or other medicines that suppress the immune system after organ transplantation, or used to treat autoimmune diseases or severe rheumatological or dermatological conditions,
tetracosactide (to treat Crohn's disease),
methadone (used to treat addiction).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
This medicine is not recommended during pregnancy.
If you are planning a pregnancy or have confirmed pregnancy, switching to an alternative treatment should be initiated as soon as possible. Inform your doctor if you are pregnant or planning a pregnancy.
Breastfeeding is not recommended while taking this medicine, as the active substance is excreted in breast milk.

Driving and using machines
This medicine may cause adverse effects related to low blood pressure such as dizziness or fatigue (see section 4). These adverse effects are more likely to occur at the beginning of treatment or after a dose increase. If this happens, you must refrain from driving or performing any activity requiring alertness. However, under proper medical supervision, such adverse effects are unlikely to occur.
Natrilix 1.5 mg prolonged-release tablets contain monohydrate lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take Natrilix 1.5 mg prolonged-release tablets

Take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet daily, preferably in the morning. The tablets can be taken regardless of meals. The tablets must be swallowed whole with water. Do not crush or chew them.
Treatment for hypertension is usually lifelong.
If you take more Natrilix 1.5 mg prolonged-release tablets than you should
If you have taken too many tablets, contact your doctor or pharmacist immediately.
At very high doses, NATRILIX 1.5 mg prolonged-release tablets may cause nausea, vomiting, low blood pressure, cramps, dizziness, drowsiness, confusion, and changes in the amount of urine produced by the kidneys.
If you forget to take Natrilix 1.5 mg prolonged-release tablets
If you forget to take a dose, take the next dose at your usual time. Do not take a double dose to make up for the forgotten dose.
If you stop taking Natrilix 1.5 mg prolonged-release tablets
Since treatment for hypertension is usually lifelong, speak with your doctor before stopping treatment with this medicine.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you notice any of the following serious side effects, stop taking the medicine and consult your doctor
immediately:

Angioedema and/or urticaria. Angioedema is characterised by swelling of the skin of the extremities or face, swelling of the lips or tongue, swelling of the mucous membranes of the throat or airways causing shortness of breath or difficulty swallowing. If this occurs, contact your doctor immediately (very rare) (may affect up to 1 in 10,000 people)
Severe skin reactions, including severe rash, redness of the skin over the entire body, intense itching, blisters, peeling and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome) or other allergic reactions (very rare) (may affect up to 1 in 10,000 people)
Irregular heartbeat that may be life-threatening (not known)
Inflammation of the pancreas which may cause severe abdominal and back pain accompanied by a strong feeling of illness (very rare) (may affect up to 1 in 10,000 people)
Brain disease caused by liver disease (hepatic encephalopathy) (not known)
Inflammation of the liver (hepatitis) (not known)
Muscle weakness, cramps, tenderness or pain, and particularly if, at the same time, you feel unwell or have a high fever, this may be due to abnormal muscle breakdown (not known).

In order of decreasing frequency, side effects may include:
Common (may affect up to 1 in 10):

Raised red rash
Allergic reactions, mainly dermatological, in individuals predisposed to allergic and asthmatic reactions
Low levels of potassium in the blood

Uncommon (may affect up to 1 in 100):

Vomiting
Small red spots on the skin (purpura)
Low levels of sodium in the blood which may lead to dehydration and reduced blood pressure
Impotence (inability to achieve or maintain an erection)

Rare (may affect up to 1 in 1,000):

Feeling of tiredness, headache, tingling (paraesthesia), dizziness
Gastrointestinal disorders (such as nausea, constipation), dry mouth
Low levels of chloride in the blood
Low levels of magnesium in the blood

Very rare (may affect up to 1 in 10,000):

Changes in blood cells, such as thrombocytopenia (reduced number of platelets causing easy bruising and nosebleeds), leucopenia (reduced white blood cells which may cause unexplained fever, sore throat or other flu-like symptoms – if this occurs, contact your doctor) and anaemia (reduced red blood cells)
Increased levels of calcium in the blood
Irregular heart rhythm, low blood pressure
Kidney disease
Abnormal liver function

Not known (frequency cannot be estimated from available data):

Fainting
If you suffer from systemic lupus erythematosus (a type of collagen disease), your condition may worsen
Cases of photosensitivity reactions (skin changes) after exposure to sunlight or artificial UVA rays have also been reported
Myopia
Blurred vision
Visual disturbances
Decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
Laboratory test parameters (blood tests) may change and your doctor may ask you to undergo follow-up blood tests. Laboratory parameters may change as follows: increased uric acid, a substance that may cause or worsen gout (joint pain, especially in the feet); increased blood glucose levels in diabetic patients; increased liver enzyme levels; abnormal ECG trace.

Reporting of side effects
If you experience any side effects, 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 Natrilix 1.5 mg prolonged-release tablets

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack.
The expiry date refers to the last day of that month.
Store below 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Natrilix 1.5 mg prolonged-release tablets contain
The active substance is indapamide. Each tablet contains 1.5 mg of indapamide.
The other components are:
Tablet core: colloidal anhydrous silica (E551), hypromellose (E464), monohydrate lactose, magnesium stearate (E470B), povidone.
Coating (film-coat): glycerol (E422), hypromellose (E464), macrogol 6000, magnesium stearate (E470B), titanium dioxide (E171).

Description of the appearance of Natrilix 1.5 mg prolonged-release tablets and contents of the pack
The medicine is presented as a film-coated, prolonged-release, round, white tablet.
The tablets are available in blisters of 10, 14, 15, 20, 30, 50, 60, 90 or 100 tablets in a cardboard box. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Les Laboratoires Servier
50, rue Carnot
92284 Suresnes cedex
France

Local Representative of the Marketing Authorisation Holder
Servier Italia S.p.A.
Via Luca Passi, 85
00166 Roma
Italy

Manufacturers
Les Laboratoires Servier Industrie
905 route de Saran
45520 Gidy
France

and
Servier (Ireland) Industries Ltd
Gorey Road
Co. Wicklow-Arklow
Ireland

and
ANPHARM Przedsiębiorstwo Farmaceutyczne S.A.
Ul. Annopol 6B - 03-236 Warszawa
POLAND

Delpharm Bretigny
Usine du Petit Paris
91220 Bretigny sur Orge
France

This medicinal product is authorised in the European Economic Area Member States under the following names:
Austria FLUDEX RETARD 1.5 mg
Belgium FLUDEX 1.5 mg
Cyprus FLUDEX 1.5 mg
Denmark NATRILIX RETARD
Estonia TERTENSIF SR
Finland NATRILIX RETARD 1.5 mg
France FLUDEX 1.5 mg
Germany NATRILIX SR 1.5 mg
Greece FLUDEX 1.5 mg
Hungary PRETANIX
Ireland NATRILIX SR
Italy NATRILIX 1.5 mg prolonged-release tablets
Latvia TERTENSIF SR
Lithuania TERTENSIF SR
Luxembourg FLUDEX 1.5 mg
Malta NATRILIX SR
Netherlands FLUDEX SR 1.5 mg
Portugal FLUDEX LP
Slovakia TERTENSIF SR
Slovenia TERTENSIF SR
Spain TERTENSIF RETARD
United Kingdom NATRILIX SR
(Northern Ireland)