PACKAGE LEAFLET

PROTIADEN 75 mg

film-coated tablets
Dotiepina hydrochloride
Please read all of this leaflet carefully before you start 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 other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including any not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What PROTIADEN 75 mg film-coated tablets are and what they are used for
What you need to know before taking PROTIADEN 75 mg film-coated tablets
How to take PROTIADEN 75 mg film-coated tablets
Possible side effects
How to store PROTIADEN 75 mg film-coated tablets
Contents of the pack and other information

1. What PROTIADEN 75 mg film-coated tablets is and what it is used for

PROTIADEN belongs to a group of medicines known as "non-selective monoamine reuptake inhibitor antidepressants".
It is used to treat depressive states and anxiety often associated with depressive disorders.

2. What you should know before taking PROTIADEN 75 mg, coated tablets

Do not use PROTIADEN 75 mg, coated tablets

If you are allergic to dothiepine or to any of the other ingredients of this medicine (listed in section 6). Cases of cross-allergy with other drugs of similar chemical structure have been reported.
If you have glaucoma (increased pressure inside the eye).
If you suffer from prostatic hypertrophy (enlarged prostate).
If you suffer from severe myasthenia gravis (a rare muscle disease).
If you have recently had a myocardial infarction.
If you suffer from severe liver disease.
If you are already being treated with another antidepressant.

To avoid serious adverse events, which may include seizures, coma, and cessation of vital functions, this medicine must not be administered concurrently with monoamine oxidase inhibitors (other antidepressant medicines), nor within at least two weeks after discontinuation of treatment with such medicines.

In children and adolescents under 18 years of age.

If you are due to undergo surgery, you must stop treatment at least 3–5 days beforehand.

Warnings and precautions

Talk to your doctor or pharmacist before taking PROTIADEN.
This medicine must be used under direct medical supervision.
Inform your doctor of any other current or previous illness, as taking this medicine requires caution, particularly:

If you have previously experienced episodes of epilepsy or seizures
If you suffer from heart disease, especially if you are elderly
If you suffer from cerebral atherosclerosis
If you have previously experienced urinary retention
If you suffer from intestinal obstruction
If you suffer from pyloric stenosis
If you suffer from severe kidney or liver disease
If you suffer from hyperthyroidism
If you are being treated with thyroid hormones

Glaucoma: PROTIADEN must not be administered to patients with closed-angle glaucoma. In patients with chronic simple glaucoma, the risk that PROTIADEN may increase intraocular pressure is relatively low when administered together with specific glaucoma treatment.

Suicidal thoughts and worsening of depression or anxiety:
Depression is associated with an increased risk of suicidal thoughts, self-harm, and suicide (suicide/suicide-related events). This risk persists until a significant improvement occurs. Since clinical improvement may not occur during the first few weeks of treatment or immediately thereafter, patients must be closely monitored until improvement occurs. Clinical experience shows that the risk of suicide may increase in the early stages of improvement.
Other psychiatric disorders for which PROTIADEN is prescribed may also be associated with an increased risk of suicidal behaviour. These conditions may also be associated with major depressive disorder. Therefore, the same precautions applied when treating patients with major depressive disorder should be followed when treating patients with other psychiatric disorders.
Patients with a history of suicidal behaviour or suicidal thoughts, or those exhibiting a significant degree of suicidal ideation before starting treatment, are at higher risk of suicidal thoughts or suicide attempts and must be closely monitored during treatment.
Treatment should always be accompanied by close monitoring of patients, particularly those at high risk, especially at the beginning of treatment and when the dose is changed.
It is important that you (or the person caring for you) pay attention and immediately report to your doctor any worsening of symptoms, the emergence of suicidal thoughts or behaviours, or changes in behaviour.
Do not stop treatment abruptly, as sudden discontinuation may cause specific symptoms (see section 3).

Use in children and adolescents under 18 years of age
Tricyclic antidepressants must not be used to treat children and adolescents under 18 years of age.

Other medicines and PROTIADEN 75 mg, coated tablets
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take this medicine concurrently or within 14 days after stopping treatment with a monoamine oxidase inhibitor (MAOI) antidepressant.
Special medical supervision is required in the following cases:
PROTIADEN has an effect that enhances the action of alcohol, analgesics (painkillers), and narcotic drugs; the same effect may occur when administered concomitantly with adrenaline and noradrenaline (often present in local anaesthetic preparations).
PROTIADEN counteracts the hypotensive effect of certain antihypertensive agents (betanidine, methyldopa, reserpine, dibenzochine, and guanethidine).
Concomitant use with other medicines such as psychotropics, anticholinergics, antihistamines, or sympathomimetics requires special caution and medical supervision to avoid unexpected side effects due to interactions.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

In pregnant women, this medicine should be administered only if clearly necessary and under direct medical supervision.
The medicine passes into breast milk in small amounts, so it is unlikely to cause problems.

PROTIADEN and alcohol
PROTIADEN has an effect that increases the action of alcohol.

Driving and using machines
This medicine may negatively affect your reaction time when performing activities requiring special attention.

PROTIADEN 75 mg, coated tablets contain sucrose and glucose:
If your doctor has diagnosed you with an intolerance to certain sugars, consult him/her before taking this medicine.
May be harmful to teeth.

3. How to take PROTIADEN 75 mg, coated tablets

Dosage, method and frequency of administration
PROTIADEN may be administered in doses ranging from 75 to 150 mg daily.

Mild to moderate depression: 75 mg once daily in the evening as a single dose.
Moderate to severe depression: 150 mg daily, either in divided doses or as a single dose in the evening. If the latter regimen is used, divided doses are preferred during the first few days. Single evening dosing is recommended because it ensures 24-hour therapeutic coverage and at the same time facilitates sleep in depressed patients and reduces discomfort due to dry mouth.

In elderly patients, dosage must be carefully determined by the physician, who should consider reducing the doses indicated above.
If you take more PROTIADEN 75 mg, coated tablets than you should
In case of accidental ingestion/overdose of PROTIADEN, inform your doctor immediately or go to the nearest hospital.
If you stop taking PROTIADEN 75 mg, coated tablets
Do not stop treatment abruptly, as sudden discontinuation may cause symptoms mainly consisting of relapse, malaise, nausea, headache, and myalgia; however, these are not related to dependence.
Therefore, it is recommended to gradually reduce the treatment.
If you have any doubts about the use of PROTIADEN, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not
everyone experiences them.

More frequent side effects:
dry mouth,
visual accommodation disorders, mydriasis (pupil dilation),
constipation,
asthenia (marked fatigue),
tachycardia (increased heart rate),
palpitations,
tinnitus (ringing in the ears),
headache,
drowsiness,
orthostatic hypotension (sudden drop in blood pressure upon rapidly changing from lying or sitting position to standing).
Following the use of high doses, the following have been reported:
mild to severe and persistent tremors,
ataxia (disturbance of balance and motor coordination), incoordination,
paresthesia (tingling, prickling sensations),
peripheral neuropathy (disease of peripheral nerves),
allergic reactions with skin rashes,
increased skin sensitivity to light,
swelling of the face or tongue,
very rarely: gynecomastia in men (enlargement of breast tissue) and galactorrhea in women (milk production outside the breastfeeding period).
In patients with initial signs of delirium or personality disorders characterized by distrust and suspicion that others may harm them, especially if elderly: transitions from depressive states to excited states associated with confusion, hallucinations, anxiety, and insomnia have been reported. In case of psychotic manifestations, the physician might prescribe an additional treatment (e.g. with phenothiazine) alongside PROTIADEN.
Rarely:
suicidal thoughts/suicidal behaviour (see section Warnings and precautions). In depressed patients, the possibility of suicide should always be considered.
EEG (electroencephalogram) abnormalities.
Although sometimes reported with the use of certain groups of medicines, mainly in cases of overdose, it is not possible to establish a definite causal relationship between the following symptoms and antidepressant treatment:
gastrointestinal disorders such as nausea, vomiting, stomatitis (inflammation of the mouth), sublingual or parotid salivary gland adenitis (inflammation of the parotid gland), diarrhea, abdominal pain, hepatitis (liver inflammation), and jaundice (yellowing of the skin and whites of the eyes);
agranulocytosis (reduction in the number of certain white blood cells called granulocytes), thrombocytopenic purpura (appearance of micro-haemorrhages and blood spots on the skin due to lack of certain blood cells called platelets);
urinary retention (difficulty passing urine);
paralytic ileus (intestinal obstruction due to paralysis of the small intestine);
alopecia (hair loss);
changes in libido (sexual desire);
changes in body weight or blood glucose levels;
cardiovascular effects, particularly in elderly patients, including ECG changes, cardiac block, myocardial infarction, stroke.

An increased risk of bone fractures has been observed in patients taking this type of medicine.

Following the instructions provided in this leaflet reduces the risk of side effects,
although not everyone will experience them.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet,
please contact your doctor, pharmacist, or nurse. You may also report side effects
directly via the national reporting system at
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 PROTIADEN 75 mg, coated tablets

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month.
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 PROTIADEN 75 mg, coated tablets contain
The active substance is:
dotiepin hydrochloride 75 mg per coated tablet
The other components are: maize starch, titanium dioxide, tricalcium phosphate, white wax, glucose, sandarac gum, magnesium stearate, povidone, sucrose, talc.
Description of the appearance of PROTIADEN 75 mg, coated tablets and package contents
PROTIADEN is presented in a carton containing 30 tablets in blisters.
Marketing Authorization Holder
TEOFARMA S.r.l. - Via F.lli Cervi, 8 - 27010 Valle Salimbene (PV)
Manufacturer
TEOFARMA S.r.l. - Viale Certosa, 8/A - 27100 Pavia