SINEQUAN 25 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Sinequan 25 mg Hard Capsules

Doxepin

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Sinequan and what is it 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 further information

1. What is Sinequan and what is it used for

Sinequan belongs to a group of medicines called tricyclic antidepressants. It contains the active substance doxepin.

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

2. What you need to know before taking Sinequan

Do not take Sinequan if:

• you are allergic to doxepin or any of the other ingredients of this medicine (listed in section 6).
• you have high eye pressure (glaucoma).
• you have urinary retention.
• you are taking, or have taken in the last 14 days, another medicine known as a monoamine oxidase inhibitor (MAOI) (see "Taking doxepin with other medicines").

Warnings and precautions

Talk to your doctor or pharmacist before taking Sinequan if:

• you are pregnant or trying to become pregnant or are 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 suffer from an anxiety disorder, you may sometimes have thoughts of self-harm or suicide. These can increase when taking antidepressants for the first time, as all these medicines require time to start working, usually around two weeks, although in some cases it may take longer.

You are 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 data have shown an increased risk of suicidal behavior in young adults (under 25 years) with psychiatric disorders who were treated with an antidepressant.

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

It may be helpful for you to tell a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this package 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 elderly people, caution is required with certain side effects such as blurred vision, dizziness, loss of balance, or low blood pressure when standing up.

Talk to your doctor, even if any of the above circumstances have occurred to you in the past.

Taking doxepin with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Sinequan may interact with the following medicines:

• MAOIs.
• Other antidepressants, barbiturates, or other sleeping medicines or other anxiety medicines, and may increase their effects.
• Blood pressure-lowering medicines.
• Sympathomimetics: decongestant medicines (used for colds and allergic rhinitis) and bronchodilators (for the treatment of asthma).
• Cimetidine (for the treatment of ulcers and stomach discomfort).
  • Tolazamide (antidiabetic that lowers blood sugar).

Taking Sinequan with food, drinks, and alcohol

If you drink alcohol while being treated with doxepin, the alcohol may affect you more than usual.

Avoid taking this medicine with food.

Pregnancy, breastfeeding, and fertility

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

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

Driving and using machines

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

3. How to take Sinequan

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

Remember to take your medicine.

The recommended initial dose of doxepin in adults is 75 mg per day (3 capsules), but your doctor will indicate 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 the case of elderly patients or those with liver or kidney problems, the doctor may recommend a lower dose.

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

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

Talk to your doctor about how long you should take the medicine. The effect may take up to 2 or 3 weeks to appear from the start of treatment. Do not stop taking doxepin or change your dose without consulting your doctor. It is essential to treat your illness properly to help you improve. If left untreated, your illness may not disappear and may become more severe and more difficult to treat.

If you think the action of Sinequan is too strong or too weak, tell your doctor or pharmacist.

If you take more Sinequan than you should

In case of severe overdose, you may experience: reduced breathing, convulsions, 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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

The symptoms of overdose may be drowsiness, stupor, blurred vision, and excessive dryness of the mouth.

If you forget to take Sinequan

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

If you stop taking Sinequan

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

It may be necessary to gradually reduce the dose until you completely stop treatment. This will prevent the original problem from appearing again and will prevent effects such as insomnia, irritability, or excessive sweating.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. These 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, tremors, 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 , dizziness, subjective sensation of ringing in the ears (tinnitus), skin rashes, facial swelling, mouth ulcers, urine retention, weakness.

Rare side effects (may affect up to 1 in 1,000 patients):alterations in blood cells (eosinophilia, agranulocytosis, leukopenia, thrombocytopenia), purple spots on the skin, alterations in the secretion of antidiuretic hormone, alteration (increase or decrease) of blood sugar levels, disorientation, involuntary movements, convulsions, pupil dilation (mydriasis), arrhythmias, hypertension, postural hypotension, worsening of asthma symptoms, intestinal obstruction, yellowing of the skin, abnormal hair loss, photosensitivity, decreased sexual appetite, testicular inflammation, breast swelling, and in women, breast secretion, chills.

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

If you notice any other reaction not mentioned in this package leaflet, talk to your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website, http://www.aemps.gob.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sinequan

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

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

Do not use this medicine after the expiration date stated on the package, after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Sinequan

The active substance is doxepin hydrochloride.

The other ingredients (excipients) are:

Capsule content: corn starch, magnesium stearate, sodium lauryl sulfate.

Capsule shell: erythrosine, indigo carmine, titanium dioxide, and gelatin, q.s.

Appearance of the product and pack contents

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

Marketing authorization holder and manufacturer

Marketing authorization holder

Farmasierra Laboratorios, S.L.

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

28709 Madrid, Spain

Manufacturer

Farmasierra Manufacturing, S.L.

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

28709 Madrid, Spain

Date of the last revision of this package leaflet:September 2023

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS), http://www.aemps.gob.es.