Package Insert: Information for the User

StopCold 5 mg/120 mg Extended-Release Tablets

(cetirizine dihydrochloride, pseudoephedrine hydrochloride)

Read this package insert carefully before starting to take this medication, as it contains important information for you.

-Keep this package insert, as you may need to refer to it again.

-If you have any questions, consult your doctor or pharmacist.

-This medication has been prescribed for you only, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

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

1. What is StopCold and for what it is used

2. What you need to know before starting to take StopCold

3. How to take StopCold

4. Possible adverse effects

5. Storage of StopCold

6. Contents of the package and additional information

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

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

Do not take StopCold:

• If you are allergic to the active ingredients, to ephedrine, to any piperazine, or to any of the other components of this medication (listed in section 6).
• If you have severe high blood pressure (hypertension) or uncontrolled hypertension, serious heart problems, or severe irregular heart rhythms (arrhythmias).
• If you are being treated with migraine medications that contain dihydroergotamine.
• If you have uncontrolled hyperthyroidism.
• If you are being treated with antidepressants (monoamine oxidase inhibitors).
• If you have severe, acute, or chronic kidney disease, or kidney failure, if you have kidney disease in the terminal stage (patients with a Glomerular Filtration Rate (GFR) less than 15 ml/min), prostate hypertrophy.
• If you have difficulty urinating (urinary retention).
• If you have angle-closure glaucoma.
• If you have a history or high risk of stroke.
• If you have a tumor in the adrenal gland (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 palpitations, irregular heart rhythms, heart problems (heart failure), liver problems, or are elderly.

• 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 medications (decongestants, appetite suppressants, stimulants), tricyclic antidepressants, or cardiac glycosides (see use of other medications).

• If you take alcohol or any other central nervous system depressant, as it may cause problems performing actions.

• If you are taking vasoconstrictor medications (bromocriptine, pergolide, lisuride, cabergoline, ergotamine) or any other oral or nasal decongestant (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, benign prostatic hyperplasia, prostate 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 nonsteroidal anti-inflammatory drugs.

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

• If you have blood clotting problems.

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

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

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

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

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

Children

StopCold is contraindicated in children under 2 years old.

Use of StopCold with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

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

It is essential to inform your doctor if you are taking or have taken recently any of the following medications:

• Certain medications used to treat depression (monoamine oxidase inhibitors).
• Certain medications used to lower blood pressure; antihypertensives (beta-blockers).
• Some medications used to treat stomach pain (antacids).
• Certain medications used to treat high blood pressure (methyldopa, guanethidine, or reserpine).
• Medications used to treat heart problems (cardiac glycosides).
• Antibiotics containing linezolid.
• Certain medications used in anesthesia (halogenated anesthetics).
• Certain sympathomimetic medications (decongestants, appetite suppressants, stimulants).
• Certain vasoconstrictor medications (bromocriptine, pergolide, lisuride, cabergoline, ergotamine).
• Nonsteroidal anti-inflammatory drugs.

Use of StopCold with food, drinks, and alcohol

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

It is not recommended to take alcohol or fatty foods as it may reduce 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 medication.

This medication is not recommended during pregnancy or breastfeeding, as the medication is excreted in breast milk.

Driving and operating machinery

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

However, it is recommended that patients who plan to drive, perform potentially hazardous activities, or operate machinery not exceed the recommended dose and consider their response to StopCold beforehand.

It is reported to athletes that this medication contains pseudoephedrine, which may result in a positive doping test.

StopCold contains pseudoephedrine, lactose, and sodium

This medication, containing pseudoephedrine, may present abuse problems, so the duration of treatment should not exceed 2 or 3 weeks.

This medication contains lactose. If your doctor has indicated that you have a lactose intolerance, consult with them before taking this medication.

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to always take your medication.

Your doctor will inform you of the duration of your treatment with StopCold. Do not discontinue treatment before.

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

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

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

If you estimate that the action of StopCold is too strong or too weak, inform 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 rhythm that can 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. Phone 915 620 420.

If you forgot to take StopCold

Do not take a double dose to compensate for the missed doses. Continue taking your regular dose when it is due.

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

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

These include:

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

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

• Common (may affect up to 1 in 10 people) are: tachycardia (irregular heart rhythm), dry mouth, nausea, fatigue, dizziness, vertigo, headache, 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 rhythm), vomiting, liver function disorders (elevated liver enzymes and bilirubin), hypersensitivity reactions (including anaphylactic shock), seizures, tremor, hallucinations, difficulty urinating, dry skin, itching, increased sweating, pallor, hypertension.
• Very rare (may affect up to 1 in 10,000 people): dysgeusia (alteration of the sense of taste), cerebral hemorrhage, mental disorders, drug-related rash, angioneuritic edema (sudden development of red patches and hives), and cardiovascular collapse.
• Frequency not known (cannot be estimated from available data): severe vascular disorders of the brain known as reversible posterior encephalopathy syndrome (REPS) and reversible cerebral vasoconstriction syndrome (RCVS), aggression, confusion, depression,involuntary movement and repetition caused by muscle contraction(tic), excessive feeling of well-being (euphoric mood), suicidal thoughts, abnormal skin sensation (paresthesia), restlessness, abnormal prolonged muscle contractions (dystonia), involuntary movements (dyskinesia), memory loss (amnesia), memory problems, fainting (syncope), ischemic colitis (inflammation of the colon due to insufficient blood supply),diarrhea, abdominal discomfort,shortness of breath (dyspnea),visual accommodation disorder (ocular disorder), blurred vision, midriasis (abnormal dilation of the pupils), eye pain, visual deterioration, photophobia (abnormal intolerance to visual perception of light),uncontrolled circular eye movements (oculogyric crisis),decreased blood flow to the optic nerve (ischemic optic neuropathy), erectile dysfunction (persistent inability to achieve and maintain an erection sufficient for a satisfactory sexual relationship), urinary incontinence (enuresis),urinary retention (difficulty emptying the bladder),generalized acute exanthematous pustulosis (severe skin reactions characterized by fever and numerous small superficial pustules on extensive red areas),itching (pruritus),palpitations, heart tissue damage that causes a stop or severe alteration of the heart rhythm due to obstruction of the artery or arteries corresponding (myocardial infarction), low blood pressure (hypotension), joint pain (arthralgia), muscle pain (myalgia), swelling (edema), discomfort.

Description of some adverse reactions:

After treatment suspension, some patients have reported itching (pruritus).

Stop the medication at the first signs of allergic reaction to StopCold treatment.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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

No special storage conditions are required.

Do not use StopCold after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need.This will help protect the environment.

Composition of StopCold

Appearance of the product and contents of the packaging

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

Each package contains 20 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder:

UCB Pharma, S.A.

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

Spain

Responsible for manufacturing:

Aesica Pharmaceuticals, S.r.l.

Via Praglia 15

I-10044 Pianezza (TO) - Italy

Last review date of this leaflet: 04/2024

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