STOPCOLD 5 mg/120 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

StopCold 5 mg/120 mg prolonged-release tablets

(cetirizine dihydrochloride, pseudoephedrine hydrochloride)

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is StopCold and what is it used for
2. What you need to know before you take StopCold
3. How to take StopCold
4. Possible side effects
5. Storage of StopCold
6. Contents of the pack and other information

1. What is StopCold and what is it used for

StopCold is an antiallergic agent that belongs to a class of compounds called antihistamines associated with a decongestant agent.

StopCold is used for the treatment of nasal congestion and other symptoms associated with chronic or seasonal allergic rhinitis (such as nasal itching, eye itching, sneezing, discharge, and nasal congestion).

2. What you need to know before you take StopCold

Do not take StopCold:

• If you are allergic to the active substances, to ephedrine, to any piperazine, or to any of the other components of this medicine (listed in section 6).
• If you have very high blood pressure (severe hypertension) or uncontrolled hypertension, severe heart problems, or serious irregular heart rhythms (arrhythmias).
• If you are being treated with medicines for migraine that contain dihydroergotamine.
• If you have uncontrolled hyperthyroidism.
• If you are being treated with antidepressants (monoamine oxidase inhibitors).
• If you have severe kidney disease, acute (sudden) or chronic (long-term), or kidney failure, if you have end-stage kidney disease (patients with a Glomerular Filtration Rate (GFR) below 15 ml/min), prostate enlargement.
• If you have difficulty urinating (urinary retention).
• If you have narrow-angle glaucoma.
• If you have a history or high risk of stroke.
• If you have a tumor in the adrenal gland (called pheochromocytoma).
• If you are under 2 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take StopCold

• If you have diabetes, hyperthyroidism, high blood pressure, rapid heartbeats, irregular heart rhythms, heart problems (heart failure), liver problems, and in elderly people.

• If you have kidney problems, a smaller dose will be administered according to the severity of the kidney problems; the dose to be taken will be indicated by your doctor.

• If you are taking sympathomimetic medicines (decongestants, appetite suppressants, stimulants), tricyclic antidepressants, or cardiac glycosides (see use of other medicines).

• If you drink alcohol or any other central nervous system depressant, as you may have problems performing actions.

• If you are taking vasoconstrictor medicines (bromocriptine, pergolide, lisuride, cabergoline, ergotamine) or any other decongestant used orally or nasally (phenylephrine, ephedrine).

• If you have a medical condition where anticholinergic activity is not desired and specifically if you have factors that predispose to urinary retention (e.g., spinal cord injury, prostatic hyperplasia, prostatic hypertrophy, or bladder outlet obstruction) as StopCold may increase the risk of urinary retention.

• If you have high blood pressure and are being treated with non-steroidal anti-inflammatory drugs.

• If you are between 2 and 12 years old, as no studies have been conducted in this patient group.

• If you have blood coagulation problems.

• If you develop a generalized febrile erythema associated with pustules, stop taking StopCold and contact your doctor or seek immediate medical attention. See section 4.

• Dermatological allergy tests may give false negative results if you are taking StopCold during the 3 days prior to the tests, so you should inform your doctor of this circumstance before the tests are performed.

• Abdominal pain or rectal bleeding may occur with the use of StopCold due to colon inflammation (ischemic colitis). If these gastrointestinal symptoms appear, stop taking StopCold and contact your doctor or seek immediate medical attention. See section 4.

• A reduction in blood flow to the optic nerve may occur with StopCold. If you experience sudden loss of vision, stop taking StopCold and contact your doctor or seek immediate medical attention. See section 4.

• Cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported after the use of medicines containing pseudoephedrine. PRES and RCVS are rare diseases that may involve a reduction in blood flow to the brain. Stop using StopCold immediately and seek immediate medical attention if you experience symptoms that may be signs of PRES or RCVS (to know the symptoms, see section 4 "Possible side effects").

Children

StopCold is contraindicated in children under 2 years old.

Taking StopCold with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Certain medicines may interact with StopCold; in these cases, it may be necessary to change the dose or interrupt treatment with one of them.

It is important that you inform your doctor if you are taking or have recently taken any of the following medicines:

• Certain medicines used to treat depression (monoamine oxidase inhibitors).
• Certain medicines that lower blood pressure; antihypertensives (beta-adrenergic blockers).
• Some medicines used for stomach pain (antacids).
• Certain hypotensives (methyldopa, guanethidine, or reserpine).
• Medicines used to treat heart problems (cardiac glycosides).
• Antibiotics that contain linezolid.
• Certain medicines used in anesthesia (halogenated anesthetics).
• Certain sympathomimetic medicines (decongestants, appetite suppressants, stimulants).
• Certain vasoconstrictor medicines (bromocriptine, pergolide, lisuride, cabergoline, ergotamine).
• Non-steroidal anti-inflammatory drugs.

Taking StopCold with food, drinks, and alcohol

StopCold should be swallowed whole with the help of liquids and can be taken both on an empty stomach and with food. Do not chew or break the tablet.

It is not recommended to drink alcohol or eat fatty foods as it may decrease your ability to perform actions.

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.

The use of this medicine is not recommended during pregnancy or breastfeeding, as the medicine is excreted in breast milk.

Driving and using machines

No evidence has been shown that StopCold, taken at the recommended dose, produces alterations in attention, reaction capacity, and ability to drive.

However, it is recommended that patients who are going to drive, perform potentially hazardous activities, or use machinery do not exceed the recommended dose and take into account their response to StopCold beforehand.

Athletes are informed that this medicine contains pseudoephedrine, which may result in a positive doping test.

StopCold contains pseudoephedrine, lactose, and sodium

This medicine, as it contains pseudoephedrine, may present problems of abuse, so the duration of treatment should not exceed 2 or 3 weeks.

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially "sodium-free".

3. How to take StopCold

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 always take your medicine.

Your doctor will indicate the duration of your treatment with StopCold. Do not stop treatment before.

The recommended dose for adults and adolescents from 12 years old is 1 StopCold tablet twice a day (morning and night). The treatment should not normally exceed a period of 2 to 3 weeks.

Patients with kidney and liver problems should reduce the dose by half.

The tablet should be swallowed whole with the help of some liquid and can be taken both on an empty stomach and with food. The tablet should not be broken, chewed, or crushed.

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

If you take more StopCold than you should

If you have taken more StopCold than you should, consult your doctor or pharmacist immediately.

A significant overdose may cause increased drowsiness, feeling of fatigue, symptoms of depression, and irregular heart rhythms that may lead to unconsciousness or, on the contrary, stimulation with insomnia, hallucinations, tremors, and epileptic seizures.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Telephone 915 620 420.

If you forget to take StopCold

Do not take a double dose to make up for forgotten doses. Continue taking your normal dose when it is due.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop using StopCold immediately and seek urgent medical attention if you experience symptoms that may be signs of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).

These include:

• severe headache of sudden onset
• malaise
• vomiting
• confusion
• seizures
• changes in vision

The side effects described with StopCold, classified by frequency, are:

• frequent (may affect up to 1 in 10 people) are: tachycardia (irregular heart rhythms), dry mouth, nausea, fatigue, dizziness, drowsiness, nervousness, and insomnia.
• uncommon (may affect up to 1 in 100 people): anxiety and agitation.
• rare (may affect up to 1 in 1,000 people): arrhythmia (irregular heart rhythms), vomiting, liver function disorders (increased liver enzymes and bilirubin), hypersensitivity reactions (including anaphylactic shock), seizures, tremors, hallucinations, difficulty urinating, dry skin, itching, increased sweating, pallor, hypertension.
• very rare (may affect up to 1 in 10,000 people): dysgeusia (alteration of taste), stroke, mental disorders, drug-related rash, angioedema (sudden development of red patches and hives), and cardiovascular collapse.
• frequency not known (cannot be estimated from the available data): serious diseases affecting the blood vessels of the brain known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), aggression, confusion, depression, involuntary and repetitive movement that occurs due to the contraction of one or more muscles of the body (tic), exaggerated feeling of well-being (euphoric mood), suicidal thoughts, abnormal sensation in the skin (paresthesia), restlessness, abnormal muscle contractions (dystonia), involuntary movements (dyskinesia), memory loss (amnesia), memory problems, fainting (syncope), colon inflammation due to insufficient blood supply (ischemic colitis), diarrhea, abdominal discomfort, dyspnea (difficulty breathing), disorder of visual accommodation (eye disorder), blurred vision, mydriasis (abnormal dilation of the pupils), eye pain, visual impairment, photophobia (abnormal intolerance to light perception), uncontrolled circular movements of the eyes (oculogyric crisis), decreased blood flow to the optic nerve (ischemic optic neuropathy), erectile dysfunction (persistent inability to achieve and maintain an erection sufficient to allow a satisfactory sexual relationship), urinary incontinence (enuresis), urinary retention (difficulty emptying the bladder), acute generalized exanthematous pustulosis (severe skin reactions characterized by fever and numerous small superficial pustules, which appear in extensive areas of redness), itching (pruritus), palpitations, cardiac tissue damage that produces a stop or severe alteration of the heartbeat due to obstruction of the corresponding artery or arteries (myocardial infarction), low blood pressure (hypotension), joint pain (arthralgia), muscle pain (myalgia), swelling (edema), malaise.

Description of some adverse reactions:

After stopping treatment, itching (pruritus) has been reported in some patients.

At the first allergic symptoms to treatment with StopCold, stop the medication.

In post-marketing experience, isolated cases of hepatitis have been reported when cetirizine is administered alone.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of StopCold

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

No special storage conditions are required.

Do not use StopCold after the expiry date stated on the carton after EXP. The expiry date is the last day of the month indicated.

Medicines should 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. Contents of the pack and other information

Composition of StopCold

• The active substances are cetirizine (as dihydrochloride) and pseudoephedrine (as hydrochloride).
• The other components are: hypromellose (E 464), microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, lactose, sodium croscarmellose, titanium dioxide (E 171), macrogol 400.

Appearance of the product and contents of the pack

StopCold is presented in the form of prolonged-release tablets. They are white, round, and biconvex tablets.

Each pack contains 20 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

UCB Pharma, S.A.

Plaza de Manuel Gómez Moreno, s/n, Edificio Bronce, Planta 5, 28020 Madrid

Spain

Manufacturer:

Aesica Pharmaceuticals, S.r.l.

Via Praglia 15

I-10044 Pianezza (TO) - Italy

Date of last revision of this leaflet: 04/2024

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