Patient Information Leaflet

Sinequan 25 mg Hard Capsules

Doxepin

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

-Keep this leaflet, as you may need to read it again.

-If you are unsure about anything, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What Sinequan is and what it is used for

2.What you need to know before taking Sinequan

3.How to take Sinequan

4.Possible side effects

5.Storage of Sinequan

6.Contents of the pack and additional information

Sinequan belongs to a group of medications called tricyclic antidepressants. It contains doxepin as its active ingredient.

This medication is used to treat depression in adults. Depression is a continued alteration of mood with symptoms that usually consist of a deep feeling of sadness, feelings of uselessness, loss of interest or pleasure, sleep disturbances, a feeling of slowness, and a lack of ability to concentrate and/or a feeling of anxiety. Depression symptoms can vary from person to person.

Do not take Sinequan if:

-you are allergic to doxepin or any of the other components of this medication (listed in section 6).

-you have high eye pressure (glaucoma).

-you have urinary retention.

-you are taking, or have taken within the last 14 days, another medication known as a monoamine oxidase inhibitor (MAOI) (see “taking doxepin with other medications”)

Warnings and precautions

Consult your doctor or pharmacist before starting to take Sinequan if:

-you are pregnant or breastfeeding (see “pregnancy, breastfeeding, and fertility”)

-you have heart problems or have recently had a heart attack

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-you have kidney or liver problems.

• you have epilepsy or a history of epilepsy.

-you have had suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may occasionally have thoughts of self-harm or suicide. These may increase when you first start taking antidepressants, as it may take some time for the medication to start working, usually around two weeks, although it may take longer in some cases.

You may be more likely to have these thoughts:

• if you have previously had thoughts of self-harm or suicide.
• if you are a young adult. Clinical trial information has shown an increased risk of suicidal behavior in young adults (under 25 years) with psychiatric disorders treated with an antidepressant.

If you ever have thoughts of self-harm or suicide, contact your doctor or go directly to a hospital.

It may be helpful to tell a family member or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You can ask them if they think your depression or anxiety disorder has worsened, or if they are concerned about changes in your behavior.

• In older people, be cautious with certain side effects such as blurred vision, dizziness, loss of balance, or low blood pressure when standing up.

Consult your doctor, even if any of the above circumstances have occurred at some time.

Taking doxepin with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Sinequan may interact with the following medications:

-monoamine oxidase inhibitors.

-other antidepressants, barbiturates, or other sleep medications, or other medications for anxiety, which may increase their effects.

-blood pressure medications

-sympathomimetics: medications for nasal decongestion (used in colds and allergic rhinitis) and bronchodilators (for asthma treatment)

-cimetidine (to treat ulcers and stomach discomfort).

• tolazamide (an antidiabetic that reduces blood glucose).

Taking Sinequan with food, drinks, and alcohol

If you take alcohol while taking doxepin, the alcohol may affect you more than usual.

Avoid taking this medication with food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Only use doxepin after evaluating with your doctor the potential benefits and any potential risk to the fetus.

Driving and operating machinery

During treatment with doxepin, you may feel drowsy or dizzy. Do not drive or operate tools or machinery until you know how doxepin affects you.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

The recommended initial dose of doxepin in adults is 75 mg per day (3 capsules), but your doctor will tell you the dose that is best for you. In patients with milder symptoms, 1 or 2 capsules per day may be sufficient, and in more severe cases, higher doses may be needed, the maximum recommended dose is 300 mg per day (12 capsules per day).

In elderly patients or those with liver or kidney problems, your doctor may recommend a lower dose.

This medication should be taken orally. You should swallow the capsule whole with water and separate from meals.

The daily dose can be administered in a single dose (preferably at bedtime) or in divided doses throughout the day. If a single daily dose is administered, do not take more than 6 capsules at a time (150 mg/dose).

Discuss with your doctor for how long you should take the medication. The effect may take up to 2 or 3 weeks to appear since the start of treatment. Do not stop taking doxepin or change your dose without consulting your doctor. It is essential to treat your condition properly to help you improve. If you do not treat it, your condition may not disappear and may become more severe and harder to treat.

If you estimate that the action of Sinequan is too strong or too weak, inform your doctor or pharmacist.

If you take more Sinequan than you should

In case of severe overdose, you may experience: reduced breathing, seizures, low blood pressure, changes in heart rhythm, and palpitations

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

The symptoms of an overdose may be drowsiness, stupor, blurred vision, and excessive dry mouth

If you forgot to take Sinequan

If you forget to take a dose, take it as soon as you remember. However, if it is time for the next dose, skip the missed dose and take a single dose as you normally do. Do not take a double dose to compensate for the missed doses. Do not take more doxepin than prescribed for you in a day.

If you interrupt the treatment with Sinequan

Do not stop taking your capsules without your doctor's advice, even if you feel better.

You may need to gradually reduce the dose until you stop treatment completely. This will prevent the original problem from reappearing and avoid effects such as insomnia, irritability, or excessive sweating.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. These side effects are usually mild to moderate and often disappear within a few weeks. While taking this medicine, you may experience some of the following side effects:

Very common side effects (may affect more than 1 in 10 patients): drowsiness, blurred vision, nausea, dry mouth, and constipation.

Common side effects (may affect up to 1 in 10 patients): agitation, insomnia, dizziness, tremor, lack of coordination, extrapyramidal symptoms (difficulty walking), tachycardia, hypotension, vomiting, diarrhea, sweating, fatigue, weight gain.

Uncommon side effects (may affect up to 1 in 100 patients):loss of appetite, anorexia, confusion, hallucinations,abnormal sensation of the senses, numbness, headache,vertigo, subjective sensation of ringing in the ears (tinnitus), skin eruptions, facial swelling, mouth ulcers, urinary retention, weakness.

Rare side effects (may affect up to 1 in 1,000 patients):blood cell abnormalities (eosinophilia, agranulocytosis, leucopenia, thrombocytopenia), purple-colored skin patches, hormone antidiuretic secretion alterations, alterations (increase or decrease) in blood glucose levels, disorientation, involuntary movements, seizures, pupil dilation (mydriasis), arrhythmias, hypertension, postural hypotension, worsening of asthma symptoms, intestinal obstruction, yellowish skin discoloration, abnormal hair loss, photosensitivity, decreased sexual appetite, testicular inflammation, breast swelling, and in women, breast secretion, chills.

Side effects of unknown frequency (cannot be estimated from available data):suicidal thoughts and behaviors, increased intraocular pressure (glaucoma), abdominal pain, increased body temperature, increased risk of bone fractures.

If any other reaction not described in this leaflet is observed, consult a doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use, www.notificaram.es. By reporting side effects, you can contribute to providing more informationon the safety of this medicine.

No special storage conditions are required.Store in the original packaging.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of containers and medications you no longer need. This will help protect the environment.

Composition of Sinequan

The active ingredient is doxepin hydrochloride

The other components (excipients) are:

Contents of the capsule: cornstarch, magnesium stearate, sodium laurylsulfate.

Capsule coating: erythrosine, indigo carmine, titanium dioxide, and gelatin, etc.

Appearance of the product and contents of the packaging

Sinequan is presented in a topaz-colored glass bottle with a rose-colored aluminum cap, containing 30 or 100 capsules, packaged in a cardboard box.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Farmasierra Laboratorios, S.L.

Ctra de Irún km 26,200 San Sebastián de los Reyes

28709 Madrid. Spain

Responsible for manufacturing

Farmasierra Manufacturing, S.L.

Ctra de Irún km 26,200 San Sebastián de los Reyes

28709 Madrid. Spain

Last review date of this leaflet:September 2023

The detailed information of this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es